Company ยท US
Dade Behring, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2010. Name variants (Inc, Corp, punctuation) are merged.
343510(k) clearances (0 in 12 months)
29recalls (0 in 12 months)
25recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 38 |
| JIT | Calibrator, Secondary | 29 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 23 |
| JIX | Calibrator, Multi-Analyte Mixture | 18 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 13 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 10 |
| GKP | Instrument, Coagulation, Automated | 9 |
| MMI | Immunoassay Method, Troponin Subunit | 9 |
| DLJ | Calibrators, Drug Specific | 8 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 8 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 8 |
| NBC | Test, Natriuretic Peptide | 8 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 6 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 6 |
| JIS | Calibrator, Primary | 6 |
| DDG | Transferrin, Antigen, Antiserum, Control | 5 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 5 |
| DHA | System, Test, Human Chorionic Gonadotropin | 5 |
| DKB | Calibrators, Drug Mixture | 5 |
| DKZ | Enzyme Immunoassay, Amphetamine | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 2010 | K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 Dade Behring, Inc. | GGN |
| Jul 28, 2008 | K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST Dade Behring, Inc. | CFN |
| Jul 21, 2008 | K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM Dade Behring, Inc. | DEB |
| Jun 25, 2008 | K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) Dade Behring, Inc. | DHX |
| Jun 4, 2008 | K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 Dade Behring, Inc. | LOJ |
| Mar 13, 2008 | K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD Dade Behring, Inc. | CEC |
| Feb 26, 2008 | K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR Dade Behring, Inc. | CFN |
| Feb 21, 2008 | K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B Dade Behring, Inc. | JHM |
| Jan 3, 2008 | K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 Dade Behring, Inc. | JFY |
| Dec 21, 2007 | K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON Dade Behring, Inc. | DBA |
| Dec 12, 2007 | K072717 | DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 Dade Behring, Inc. | JIT |
| Nov 13, 2007 | K071224 | DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR Dade Behring, Inc. | CDD |
| Oct 17, 2007 | K072435 | DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H Dade Behring, Inc. | JIX |
| Sep 19, 2007 | K072304 | FIBRINOGEN CALIBRATOR KIT Dade Behring, Inc. | GFX |
| Sep 11, 2007 | K071980 | DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H Dade Behring, Inc. | JJY |
| Aug 24, 2007 | K071811 | ETOH FLEX REAGENT CARTRIDGE (DF22) Dade Behring, Inc. | DIC |
| Aug 20, 2007 | K071317 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN Dade Behring, Inc. | LON |
| Aug 20, 2007 | K071316 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN Dade Behring, Inc. | LRG |
| Aug 17, 2007 | K071834 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM Dade Behring, Inc. | NBC |
| Aug 8, 2007 | K071247 | N LATEX RF KIT Dade Behring, Inc. | DHR |
| Aug 4, 2007 | K071767 | DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A Dade Behring, Inc. | NBC |
| Jul 18, 2007 | K070346 | DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM Dade Behring, Inc. | LON |
| Jun 26, 2007 | K071268 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE Dade Behring, Inc. | LON |
| Jun 13, 2007 | K070853 | DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 Dade Behring, Inc. | DIC |
| May 21, 2007 | K071076 | SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS Dade Behring, Inc. | LON |
| May 11, 2007 | K070860 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN Dade Behring, Inc. | LON |
| Apr 30, 2007 | K070552 | DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) Dade Behring, Inc. | JIT |
| Mar 23, 2007 | K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK Dade Behring, Inc. | DAP |
| Mar 21, 2007 | K063663 | DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H Dade Behring, Inc. | DDG |
| Mar 19, 2007 | K063756 | DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE Dade Behring, Inc. | MMI |
| Feb 23, 2007 | K063754 | DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 Dade Behring, Inc. | DHA |
| Feb 23, 2007 | K063608 | DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH Dade Behring, Inc. | MSJ |
| Feb 15, 2007 | K063655 | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH Dade Behring, Inc. | CHN |
| Feb 15, 2007 | K063425 | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH Dade Behring, Inc. | DGC |
| Feb 8, 2007 | K063564 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) Dade Behring, Inc. | LON |
| Jan 26, 2007 | K063272 | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH Dade Behring, Inc. | JZG |
| Jan 24, 2007 | K063322 | DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H Dade Behring, Inc. | DDG |
| Jan 23, 2007 | K063508 | DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN Dade Behring, Inc. | JIX |
| Jan 22, 2007 | K063351 | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH Dade Behring, Inc. | NDY |
| Jan 11, 2007 | K063610 | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH Dade Behring, Inc. | DEM |
| Dec 28, 2006 | K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH Dade Behring, Inc. | LPS |
| Dec 26, 2006 | K062924 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK Dade Behring, Inc. | NQD |
| Dec 8, 2006 | K063366 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE Dade Behring, Inc. | LON |
| Dec 8, 2006 | K063365 | SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE Dade Behring, Inc. | LON |
| Nov 27, 2006 | K063299 | MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN Dade Behring, Inc. | LRG |
| Nov 20, 2006 | K062938 | MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML Dade Behring, Inc. | LON |
| Nov 9, 2006 | K063102 | MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) Dade Behring, Inc. | LRG |
| Nov 1, 2006 | K063101 | MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML Dade Behring, Inc. | LRG |
| Nov 1, 2006 | K063099 | MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) Dade Behring, Inc. | LRG |
| Oct 27, 2006 | K063065 | MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) Dade Behring, Inc. | LRG |
Newest 50 of 343.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2009 | Dade Behring, Inc. Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. Terminated |
JHX | K051650 |
| Jan 13, 2009 | Dade Behring, Inc. Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3.
The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that Terminated |
JJE | K073604 |
| Dec 13, 2008 | Dade Behring, Inc. Dimension Enzymatic Creatinine Flex reagent cartridge, DF270.
The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Terminated |
JFY | K073055 |
| Aug 22, 2007 | Dade Behring, Inc. EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE. Terminated |
JJE | K051087 |
| Dec 5, 2006 | Dade Behring, Inc. Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D; Terminated |
LIE | K820299 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CpBNP-D) in vitro diagnostic. Terminated |
NBC | K043476 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic. Terminated |
DDR | K984065 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic. Terminated |
DAP | K022976 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic. Terminated |
MMI | K981098 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic. Terminated |
JHX | K981099 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic. Terminated |
DHA | K003696 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer Acute Care pBNP TestPak (CpBNP) in vitro diagnostic. Terminated |
NBC | K043476 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic. Terminated |
DDR | K984065 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic. Terminated |
DAP | K051597 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic. Terminated |
MMI | K033487 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic. Terminated |
JHX | K984067 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic. Terminated |
DHA | K003696 |
| Dec 23, 2005 | Dade Behring , Inc. Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100 Terminated |
GGW | K811589 |
| Nov 18, 2005 | Dade Behring , Inc. Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method. Terminated |
DAP | K041438 |
| Aug 16, 2005 | Dade Behring , Inc. Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test Terminated |
GJT | K924396 |
| Jul 22, 2005 | Dade Behring , Inc. Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E Terminated |
GHH | K872360 |
| Apr 6, 2005 | Dade Behring MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691 Terminated |
LON | None listed |
| Feb 15, 2005 | Dade Behring , Inc. Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13. Terminated |
DAP | K041438 |
| Dec 28, 2004 | Dade Behring , Inc. StreamLab Analytical Workcell. General Purpose Laboratory Device. Terminated |
JJE | None listed |
| Oct 23, 2004 | Dade Behring , Inc. DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies. Terminated |
JPA | K011665 |
| Oct 5, 2004 | Dade Behring , Inc. BC Thrombin Reagent . Thrombin Time Test Terminated |
GJA | K970645 |
| Jul 31, 2004 | Dade Behring , Inc. Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit. Terminated |
KFF | None listed |
| Jul 20, 2004 | Dade Behring , Inc. Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials Terminated |
GFO | K955450 |
| May 29, 2003 | Dade Behring Inc Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton. Terminated |
LTJ | None listed |