Company ยท US
American Dade
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1987. Name variants (Inc, Corp, punctuation) are merged.
149510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 9 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 9 |
| GIO | Tube, Collection, Capillary Blood | 5 |
| JPK | Mixture, Hematology Quality Control | 5 |
| JIT | Calibrator, Secondary | 4 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 3 |
| GJS | Test, Time, Prothrombin | 3 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 3 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 |
| KHQ | Radioassay, Triiodothyronine Uptake | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 |
| DIF | Drug Mixture Control Materials | 2 |
| GGW | Test, Time, Partial Thromboplastin | 2 |
| JIY | Photometric Method, Iron (Non-Heme) | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 1987 | K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | CGJ |
| Sep 29, 1987 | K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | JHX |
| Sep 14, 1987 | K873052 | STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | CEP |
| Sep 2, 1987 | K872789 | PARAMAX URINE/CSF CALIBRATOR American Dade | JIX |
| Aug 6, 1987 | K872195 | DATA-FI DIMERTEST LATEX ASSAY American Dade | DAP |
| Jul 31, 1987 | K872196 | AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III American Dade | JJS |
| Jul 21, 1987 | K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | DGE |
| Jul 9, 1987 | K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR American Dade | JJY |
| Jul 7, 1987 | K872050 | PARAMAX CHOLESTEROL REAGENT American Dade | LBS |
| Jul 6, 1987 | K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET American Dade | GHH |
| Mar 19, 1987 | K870158 | STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. American Dade | CEC |
| Feb 25, 1987 | K870406 | SMI DIGITRON American Dade | JQW |
| Feb 10, 1987 | K870354 | IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) American Dade | GGP |
| Feb 10, 1987 | K870353 | IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN) American Dade | GGP |
| Nov 13, 1986 | K864274 | THROMBOPLASTIN.R American Dade | GJS |
| Nov 13, 1986 | K864273 | THROMBOPLASTIN.C American Dade | GJS |
| Nov 13, 1986 | K864272 | THROMBOPLASTIN.FS American Dade | GJS |
| Nov 5, 1986 | K863887 | SMI MULTIPETTOR(TM) American Dade | JQW |
| Oct 17, 1986 | K863594 | ACTIN FSL ACTIVATED PTT REAGENT American Dade | GGW |
| Sep 29, 1986 | K863489 | PARAMAX ELECTROLYTE CALIBRATOR American Dade | JIX |
| Aug 19, 1986 | K862818 | STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | JJE |
| Aug 19, 1986 | K862428 | STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | JLW |
| Aug 4, 1986 | K862440 | PARAMAX LIPASE REAGENT American Dade | CET |
| Jun 16, 1986 | K862067 | STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | LFM |
| May 29, 1986 | K860906 | STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III American Dade | JJY |
| Apr 11, 1986 | K860422 | STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY American Dade | KHQ |
| Mar 17, 1986 | K860355 | BOVINE CHEMISTRY CONTROL I.X AND II.X American Dade | JJY |
| Feb 19, 1986 | K855199 | PARAMAX COMPREHENSIVE CALIBRATOR American Dade | JIX |
| Feb 11, 1986 | K860421 | STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY American Dade | CDX |
| Feb 11, 1986 | K860141 | STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. American Dade | LAR |
| Feb 6, 1986 | K860140 | STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. American Dade | LAN |
| Dec 13, 1985 | K854651 | PARAAMAX CHLORIDE DETERMINATION BY ISE American Dade | CGJ |
| Nov 12, 1985 | K853986 | THROMBOPLASTIN-R REAGENT American Dade | JPA |
| Sep 18, 1985 | K853548 | STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS American Dade | LCM |
| Sep 16, 1985 | K853547 | STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I American Dade | LAN |
| Sep 4, 1985 | K853531 | ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER American Dade | CEM |
| Aug 29, 1985 | K853462 | COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA American Dade | GGP |
| Aug 29, 1985 | K853461 | COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA American Dade | GGP |
| Jul 9, 1985 | K852285 | DADE BLOOD GAS AMPUL INJECTOR American Dade | JQW |
| Apr 12, 1985 | K850574 | DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO American Dade | JJY |
| Apr 10, 1985 | K850575 | DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H American Dade | JJY |
| Apr 2, 1985 | K850570 | STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | JHI |
| Nov 19, 1984 | K844289 | SERIES I/S INFECTIONS American Dade | KTN |
| Nov 19, 1984 | K844158 | STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | DBF |
| Oct 1, 1984 | K842617 | VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT American Dade | GGP |
| Oct 1, 1984 | K842537 | VON WILLEBRAND FACTOR ANTIGEN SCREEN American Dade | ICF |
| Sep 26, 1984 | K843184 | STRATUS LIDOCAINE FLUOROMETRIC ENZYME American Dade | KLR |
| Sep 17, 1984 | K843183 | STRATUS CORTISOL FLUOROMETRIC ENZYME American Dade | CGR |
| Sep 12, 1984 | K843237 | STRATUS QUINIDINE FLUOROMETRIC ENZYME American Dade | LBZ |
| Jul 11, 1984 | K842196 | STRATUS PRIMIDONE FLOROMETRIC ENZY American Dade | LFT |
Newest 50 of 149.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||