Company ยท US
Dade Intl., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1998. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIT | Calibrator, Secondary | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| DKB | Calibrators, Drug Mixture | 1 |
| DKJ | Colorimetry, Salicylate | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| GKP | Instrument, Coagulation, Automated | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 1 |
| JIF | Enzymatic Method, Ammonia | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
| JOZ | System, Automated Platelet Aggregation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 1998 | K974343 | DADE INNOVIN Dade Intl., Inc. | GJS |
| Nov 17, 1997 | K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ Dade Intl., Inc. | JOZ |
| Nov 6, 1997 | K973974 | DADE TRU-LIQUID CARDIAC CONTROL Dade Intl., Inc. | JJT |
| Oct 20, 1997 | K973668 | CARDIAC TROPONIN-I (TROP) CALIBRATOR Dade Intl., Inc. | JIT |
| Sep 8, 1997 | K972524 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Dade Intl., Inc. | JWY |
| Aug 15, 1997 | K972782 | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY Dade Intl., Inc. | JHX |
| Jul 7, 1997 | K972287 | DADE TRU-LIQUID BILIRUBIN CONTROL Dade Intl., Inc. | JJX |
| Jun 4, 1997 | K964660 | PARAMAX CHOLESTEROL REAGENT Dade Intl., Inc. | CHH |
| May 2, 1997 | K970676 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS Dade Intl., Inc. | JWY |
| Apr 25, 1997 | K964715 | PARAMAX SALICYLATE REAGENT Dade Intl., Inc. | DKJ |
| Apr 14, 1997 | K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE Dade Intl., Inc. | CEM |
| Mar 28, 1997 | K964346 | PARAMAX TRIGLYCERID REAGENT Dade Intl., Inc. | CDT |
| Feb 10, 1997 | K965213 | STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY Dade Intl., Inc. | DDR |
| Feb 10, 1997 | K964862 | TROPONIN-I TEST SYSTEM Dade Intl., Inc. | MMI |
| Feb 6, 1997 | K964139 | SYSMEX CA-6000 Dade Intl., Inc. | GKP |
| Nov 22, 1996 | K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT Dade Intl., Inc. | JIF |
| Sep 23, 1996 | K963244 | ACETAMINOPHEN FLEX REAGENT CARTRIDGE Dade Intl., Inc. | LDP |
| Sep 16, 1996 | K962817 | DRUG CALIBRATOR II Dade Intl., Inc. | DKB |
| Sep 13, 1996 | K963267 | VANCOMYCIN FLEX REAGENT CARTRIDGE Dade Intl., Inc. | LEH |
| Sep 13, 1996 | K962820 | CARBAMAZEPINE FLEX REAGENT CARTRIDGE Dade Intl., Inc. | KLT |
| Sep 13, 1996 | K962819 | GENTAMICIN FLEX REAGENT CARTRIDGE Dade Intl., Inc. | LCD |
| Sep 13, 1996 | K962818 | TOBRAMYCIN FLEX REAGENT CARTRIDGE Dade Intl., Inc. | LCR |
| Aug 16, 1996 | K962150 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS Dade Intl., Inc. | LTT |
| Aug 15, 1996 | K962602 | ACA PLUS FREE THYROXINE(FT4) METHOD Dade Intl., Inc. | CEC |
| Aug 15, 1996 | K962594 | ACA PLUS FT4 CALIBRATOR Dade Intl., Inc. | JIT |
| Apr 26, 1996 | K960103 | DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS Dade Intl., Inc. | JIX |
| Jul 17, 1995 | K952250 | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT Dade Intl., Inc. | JHS |
| Jul 13, 1995 | K951890 | STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS Dade Intl., Inc. | MMI |
| Jul 13, 1995 | K951888 | DADE STRATUS TROPONIN-I CONTROL Dade Intl., Inc. | JJX |
| Jun 19, 1995 | K951332 | PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT Dade Intl., Inc. | CKA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||