Company ยท US
Baxter Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1995. Name variants (Inc, Corp, punctuation) are merged.
72510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 12 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 4 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 3 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 2 |
| GJS | Test, Time, Prothrombin | 2 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 2 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CGN | Acid, Folic, Radioimmunoassay | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| DDQ | Antigen, Antiserum, Control, Antithrombin Iii | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 18, 1995 | K934458 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Baxter Diagnostics, Inc. | JWY |
| Apr 25, 1995 | K950817 | DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI Baxter Diagnostics, Inc. | JWY |
| Apr 14, 1995 | K935704 | DRIED GRAM-NEGATIVE MIC//COMBO PANELS Baxter Diagnostics, Inc. | LTT |
| Apr 11, 1995 | K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. | JLS |
| Mar 7, 1995 | K945235 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Baxter Diagnostics, Inc. | LTT |
| Feb 16, 1995 | K941030 | DRIED GRAM-NEGATIVE CEFPODOXIME Baxter Diagnostics, Inc. | LTT |
| Feb 8, 1995 | K940917 | LORACARBEF GRAM-NAGATIVE PANELS Baxter Diagnostics, Inc. | JWY |
| Feb 3, 1995 | K941459 | GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX Baxter Diagnostics, Inc. | JWY |
| Jan 31, 1995 | K941317 | DRIED GRAM NEGATIVE/CEFMETAZOLE Baxter Diagnostics, Inc. | JWY |
| Jan 9, 1995 | K942267 | DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE Baxter Diagnostics, Inc. | JWY |
| Jan 9, 1995 | K942089 | MICRODILUTION/LORACARBEF PANELS Baxter Diagnostics, Inc. | JWY |
| Dec 2, 1994 | K943510 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Baxter Diagnostics, Inc. | JWY |
| Nov 22, 1994 | K935702 | DADE INNOVIN II Baxter Diagnostics, Inc. | GJS |
| Nov 22, 1994 | K935307 | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA Baxter Diagnostics, Inc. | DDQ |
| Nov 22, 1994 | K934003 | STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. | DKA |
| Nov 22, 1994 | K933414 | STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. | KHQ |
| Nov 18, 1994 | K944651 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Baxter Diagnostics, Inc. | JWY |
| Oct 19, 1994 | K934323 | DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL Baxter Diagnostics, Inc. | JWY |
| Aug 15, 1994 | K935987 | FLEXTRANS Baxter Diagnostics, Inc. | JSM |
| May 4, 1994 | K936196 | ANTITHROMBIN III CHROMOGENIC ASSAY Baxter Diagnostics, Inc. | JBQ |
| Apr 26, 1994 | K934275 | PARAMAX ALCOHOL REAGENT Baxter Diagnostics, Inc. | DIC |
| Mar 11, 1994 | K935568 | PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS Baxter Diagnostics, Inc. | DLZ |
| Nov 26, 1993 | K932686 | PARAMAX(R) PHENYTOIN REAGENT Baxter Diagnostics, Inc. | DIP |
| Oct 28, 1993 | K933437 | DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 Baxter Diagnostics, Inc. | JJY |
| Oct 28, 1993 | K932912 | STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC Baxter Diagnostics, Inc. | CEC |
| Oct 22, 1993 | K933464 | STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. | CHP |
| Oct 8, 1993 | K933635 | STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY Baxter Diagnostics, Inc. | JLS |
| Sep 24, 1993 | K933435 | DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 Baxter Diagnostics, Inc. | JJY |
| Sep 24, 1993 | K932685 | PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS Baxter Diagnostics, Inc. | KLS |
| Sep 22, 1993 | K933188 | DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI Baxter Diagnostics, Inc. | JPA |
| Aug 26, 1993 | K933426 | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO Baxter Diagnostics, Inc. | CDX |
| Aug 5, 1993 | K924919 | DADE(R) TUMOR MARKER CONTROL Baxter Diagnostics, Inc. | JJY |
| Jul 20, 1993 | K932082 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS Baxter Diagnostics, Inc. | JWY |
| Apr 8, 1993 | K922582 | BARTELS CYTOMEGALOVIRUS IGG EIA Baxter Diagnostics, Inc. | LFZ |
| Apr 8, 1993 | K922580 | BARTELS CYTOMEGALOVIRUS IGM EIA Baxter Diagnostics, Inc. | LKQ |
| Mar 26, 1993 | K926545 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS Baxter Diagnostics, Inc. | JWY |
| Mar 12, 1993 | K922482 | MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL Baxter Diagnostics, Inc. | LRG |
| Jan 11, 1993 | K925452 | DADE HEPZYME Baxter Diagnostics, Inc. | JBR |
| Jan 5, 1993 | K926046 | DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III Baxter Diagnostics, Inc. | JJY |
| Dec 15, 1992 | K922334 | BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA Baxter Diagnostics, Inc. | LGC |
| Dec 15, 1992 | K922333 | BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA Baxter Diagnostics, Inc. | LGC |
| Oct 26, 1992 | K924074 | STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED Baxter Diagnostics, Inc. | CDD |
| Oct 19, 1992 | K922073 | STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. | DHA |
| Sep 28, 1992 | K922583 | BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA Baxter Diagnostics, Inc. | LGC |
| Sep 18, 1992 | K922584 | BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA Baxter Diagnostics, Inc. | LGC |
| Sep 17, 1992 | K923286 | STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY Baxter Diagnostics, Inc. | CGN |
| Sep 17, 1992 | K922586 | BARTELS RUBELLA IGG EIA Baxter Diagnostics, Inc. | LFX |
| Sep 17, 1992 | K922581 | BARTELS RUBELLA IGM EIA Baxter Diagnostics, Inc. | LFX |
| Sep 2, 1992 | K922585 | BARTELS TOXOPLASMA IGG EIA Baxter Diagnostics, Inc. | LGD |
| Sep 2, 1992 | K922579 | BARTELS TOXOPLASMA IGM EIA Baxter Diagnostics, Inc. | LGD |
Newest 50 of 72.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||