Company ยท US
Prisma Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1995. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 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 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJJ | Diazo, Alt/Sgpt | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 3, 1995 | K950177 | CK QVET Prisma Systems | CGS |
| Jan 27, 1995 | K943027 | CHOLESTEROL QVET Prisma Systems | CHH |
| Dec 29, 1994 | K943042 | BUN QVET Prisma Systems | CDN |
| Dec 29, 1994 | K943001 | MAGNESIUM QVET Prisma Systems | JGJ |
| Dec 29, 1994 | K942997 | ALKALINE PHOSPHATASE (ALKP) QVET Prisma Systems | CJE |
| Dec 29, 1994 | K942964 | LACTATE DEHYDROGENASE QVET Prisma Systems | CFJ |
| Dec 29, 1994 | K942963 | GLUCOSE QVET Prisma Systems | CFR |
| Dec 13, 1994 | K944102 | AST QVET Prisma Systems | CIT |
| Dec 13, 1994 | K943000 | ALBUMIN QVET Prisma Systems | CIX |
| Dec 9, 1994 | K943026 | POTASSIUM QVET Prisma Systems | CEJ |
| Dec 9, 1994 | K943004 | TOTAL PROTEIN QVET Prisma Systems | CEK |
| Dec 9, 1994 | K943003 | CALCIUM QVET Prisma Systems | CJJ |
| Dec 9, 1994 | K942961 | AMYLASE QVET Prisma Systems | JFJ |
| Dec 9, 1994 | K942960 | PHOSPHATE QVET Prisma Systems | CEO |
| Dec 7, 1994 | K943028 | HDL QVET Prisma Systems | LBS |
| Dec 7, 1994 | K943006 | CHLORIDE QVET Prisma Systems | CHJ |
| Dec 7, 1994 | K942962 | GGT QVET Prisma Systems | JQB |
| Dec 2, 1994 | K943029 | IRON QVET Prisma Systems | JIY |
| Dec 2, 1994 | K943002 | URIC ACID QVET Prisma Systems | KNK |
| Dec 2, 1994 | K942999 | BILIRUBIN(TOTAL) QVET Prisma Systems | CIG |
| Nov 30, 1994 | K944028 | PROCHEM CHEMISTRY ANALYZER Prisma Systems | JJE |
| Nov 28, 1994 | K943012 | CALIBRATOR Prisma Systems | JIX |
| Nov 22, 1994 | K944080 | ALT QVET Prisma Systems | CKA |
| Nov 22, 1994 | K943005 | CREATININE QVET Prisma Systems | CGX |
| Nov 22, 1994 | K942998 | TRIGLYCERODES QVET Prisma Systems | CDT |
| Nov 22, 1994 | K942949 | BILIRUBIN (DIRECT) QVET Prisma Systems | CIG |
| Nov 15, 1994 | K944059 | PROCHEQ 1 & 2 Prisma Systems | JJY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||