Company ยท US
Bayer Diagnostics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2003. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKZ | Counter, Differential Cell | 2 |
| JIF | Enzymatic Method, Ammonia | 2 |
| JIT | Calibrator, Secondary | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 2 |
| MOI | System, Test, Immunological, Antigen, Tumor | 2 |
| CGN | Acid, Folic, Radioimmunoassay | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 |
| DIH | Colorimetry, Cholinesterase | 1 |
| DKB | Calibrators, Drug Mixture | 1 |
| DKJ | Colorimetry, Salicylate | 1 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 |
| GKR | System, Hemoglobin, Automated | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JPK | Mixture, Hematology Quality Control | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2003 | K033379 | BAYER SPECIAL CHEMISTRY CONTROLS Bayer Diagnostics Corp. | JJY |
| Dec 16, 2003 | K033380 | BAYER SPECIAL CHEMISTRY CALIBRATORS Bayer Diagnostics Corp. | JIX |
| Nov 14, 2003 | K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM Bayer Diagnostics Corp. | KXT |
| Sep 4, 2003 | K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY Bayer Diagnostics Corp. | DEM |
| Mar 18, 2003 | K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | KNK |
| Mar 3, 2003 | K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS Bayer Diagnostics Corp. | JJY |
| Jan 7, 2003 | K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 Bayer Diagnostics Corp. | CKB |
| Dec 24, 2002 | K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 Bayer Diagnostics Corp. | JIF |
| Dec 17, 2002 | K022177 | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | LTJ |
| Nov 27, 2002 | K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM Bayer Diagnostics Corp. | LTK |
| Nov 18, 2002 | K023184 | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM Bayer Diagnostics Corp. | DIC |
| Nov 12, 2002 | K022178 | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | MOI |
| Oct 15, 2002 | K022668 | ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD Bayer Diagnostics Corp. | GKZ |
| Oct 1, 2002 | K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | LOJ |
| Sep 24, 2002 | K022968 | ADVIA TESTPOINT CSF CONTROL Bayer Diagnostics Corp. | JPK |
| Sep 11, 2002 | K022331 | ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD Bayer Diagnostics Corp. | GKL |
| Jul 17, 2002 | K020616 | BAYER RAPIDPOINT 405 SYSTEM Bayer Diagnostics Corp. | GKR |
| Jul 13, 2002 | K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | JIF |
| Jul 11, 2002 | K020794 | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | DKJ |
| Jul 11, 2002 | K020792 | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | LDP |
| Jun 27, 2002 | K021535 | ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR Bayer Diagnostics Corp. | JIT |
| Jun 27, 2002 | K021532 | ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR Bayer Diagnostics Corp. | JIT |
| Mar 15, 2002 | K020217 | ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY Bayer Diagnostics Corp. | JJX |
| Feb 28, 2002 | K012357 | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Diagnostics Corp. | MOI |
| Jan 29, 2002 | K013959 | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS Bayer Diagnostics Corp. | DKB |
| Jan 18, 2002 | K013750 | ADVIA 1650 CHOLINESTERASE ASSAY Bayer Diagnostics Corp. | DIH |
| Dec 27, 2001 | K012183 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY Bayer Diagnostics Corp. | LGD |
| Dec 21, 2001 | K013606 | ACS 180 HOMOCYSTEINE ASSAY Bayer Diagnostics Corp. | LPS |
| Dec 18, 2001 | K013406 | ADVIA CENTAUR HOMOCYSTEINE ASSAY Bayer Diagnostics Corp. | LPS |
| Sep 21, 2001 | K012904 | ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION Bayer Diagnostics Corp. | GKZ |
| Feb 5, 2001 | K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY Bayer Diagnostics Corp. | CGN |
| Dec 5, 2000 | K003291 | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY Bayer Diagnostics Corp. | JZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||