Company ยท US
J.T. Baker Chemical Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1981. Name variants (Inc, Corp, punctuation) are merged.
54510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 4 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 4 |
| CGA | Glucose Oxidase, Glucose | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 2 |
| JFS | Coulometric, Chloride | 2 |
| JQX | Nephelometer, For Clinical Use | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| CZX | Hemopexin, Antigen, Antiserum, Control | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 3, 1981 | K803128 | SERIES 810 PLATELET ANALYZER J.T. Baker Chemical Co. | GKL |
| Oct 10, 1980 | K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT J.T. Baker Chemical Co. | JFS |
| Sep 26, 1980 | K802035 | BAKER DIAG. ULTRARATE CO2 REAGENT KIT J.T. Baker Chemical Co. | JFL |
| Sep 26, 1980 | K801909 | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC J.T. Baker Chemical Co. | DEX |
| Sep 16, 1980 | K801795 | BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. J.T. Baker Chemical Co. | JGS |
| Sep 16, 1980 | K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO J.T. Baker Chemical Co. | DEM |
| Sep 16, 1980 | K801662 | J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. J.T. Baker Chemical Co. | DEP |
| Sep 16, 1980 | K801661 | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC J.T. Baker Chemical Co. | DDB |
| Jul 21, 1980 | K801362 | ALBUMIN NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. | JQX |
| Jul 8, 1980 | K801434 | J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS J.T. Baker Chemical Co. | DDG |
| Jul 8, 1980 | K801433 | HAPTOGLOBIN NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. | DAD |
| Jul 8, 1980 | K801432 | HEMOPEXIN NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. | CZX |
| Jun 30, 1980 | K801363 | COMPLEMENT C3 NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. | CZW |
| Jun 30, 1980 | K801361 | COMPLEMENT C4 NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. | DBI |
| Jun 30, 1980 | K801283 | J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. | CZP |
| Jun 30, 1980 | K801282 | J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA J.T. Baker Chemical Co. | DFT |
| Jun 20, 1980 | K801281 | J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI J.T. Baker Chemical Co. | DEW |
| Jun 9, 1980 | K801091 | K 750 COMPUTER/DATA PROCESSOR J.T. Baker Chemical Co. | JQP |
| Jun 9, 1980 | K801090 | J.T. BAKER LSA 290 PIPETTER/DILUTER J.T. Baker Chemical Co. | JQW |
| May 28, 1980 | K801089 | J.T. BAKER NEPHELOMETER J.T. Baker Chemical Co. | JQX |
| Feb 22, 1979 | K790045 | REAGENT KIT, CHLORIDE/CARBON DIOXIDE J.T. Baker Chemical Co. | JFS |
| Feb 22, 1979 | K790044 | REAGENT KIT, BAKERS DIAGNOSTIC J.T. Baker Chemical Co. | CGX |
| Aug 17, 1978 | K781240 | ENZYMATIC TRIGLYCERIDES REAGENT KIT J.T. Baker Chemical Co. | CDT |
| Jun 6, 1978 | K780783 | AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT J.T. Baker Chemical Co. | CHH |
| Mar 3, 1978 | K772308 | AUTOZYME GLUCOSE OXIDASE (TRINDER) J.T. Baker Chemical Co. | CGA |
| Dec 6, 1977 | K772172 | DYNAZYME TM II CARDIAK-MB J.T. Baker Chemical Co. | JHW |
| Nov 3, 1977 | K771153 | DYNA ZYME II GOT 340 J.T. Baker Chemical Co. | CIT |
| Nov 3, 1977 | K771152 | DYNAZYME II GPT 340 J.T. Baker Chemical Co. | CKA |
| Oct 7, 1977 | K771790 | DETECTOTERGE AZIDE FREE J.T. Baker Chemical Co. | GKL |
| Oct 7, 1977 | K771789 | BLANKING SOLUTION HGB J.T. Baker Chemical Co. | GKR |
| Oct 7, 1977 | K771788 | CYMET-AUTOMATED J.T. Baker Chemical Co. | GGK |
| Oct 7, 1977 | K771787 | AZIDE FREE BLOOD DILUTING REAGENT J.T. Baker Chemical Co. | GIF |
| Sep 20, 1977 | K771716 | CYMET-PLUS J.T. Baker Chemical Co. | GKK |
| Aug 4, 1977 | K771085 | DYNAZYME II ALKALINE PHOSPHATASE J.T. Baker Chemical Co. | CJE |
| Aug 4, 1977 | K771084 | DYNAZYME II Y-GT J.T. Baker Chemical Co. | |
| Jul 21, 1977 | K771060 | DIAG. CONDUCTA RATE BUN REAG. SET J.T. Baker Chemical Co. | CDS |
| Jul 21, 1977 | K771059 | DIAG. OZYRATE GLUCOSE REAG. SET J.T. Baker Chemical Co. | CGA |
| Feb 1, 1977 | K761304 | JTB 700 HEMATOLOGY ANALYZER J.T. Baker Chemical Co. | JPJ |
| Jan 5, 1977 | K761345 | GLUCO-HEX TM REAGENT KIT J.T. Baker Chemical Co. | CFR |
| Jan 5, 1977 | K761344 | DYNAZYME-II TM CK-230 KIT J.T. Baker Chemical Co. | CGS |
| Jan 5, 1977 | K761343 | DYNAZYME-II TM LDH-L 340 KIT J.T. Baker Chemical Co. | CFJ |
| Nov 2, 1976 | K760412 | LDH SUBSTRATE J.T. Baker Chemical Co. | CFJ |
| Nov 2, 1976 | K760409 | SODIUM NITRITE J.T. Baker Chemical Co. | CIG |
| Nov 2, 1976 | K760408 | POTASSIUM SODIUM TARTRATE J.T. Baker Chemical Co. | CIG |
| Nov 1, 1976 | K760397 | REAGENT, AMP BUFFER DIAGNOSTIC J.T. Baker Chemical Co. | CJE |
| Oct 29, 1976 | K760411 | NAD (SPOONPAK CONTAINER) J.T. Baker Chemical Co. | CFJ |
| Oct 29, 1976 | K760410 | AMP BUFFER J.T. Baker Chemical Co. | CFJ |
| Oct 29, 1976 | K760407 | SULFANILIC ACID J.T. Baker Chemical Co. | CIG |
| Oct 29, 1976 | K760406 | CAFFEINE DILUENT J.T. Baker Chemical Co. | CIG |
| Oct 29, 1976 | K760398 | REAGENT, MAGNESIUM CHLORIDE J.T. Baker Chemical Co. | CJE |
Newest 50 of 54.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||