Prisma Systems
Rome, NY, US
Prisma Systems appears in FDA device records in Rome, NY. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Prisma Systems between 1994 and 1995. The busiest year on record is 1994, with 25. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 25 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K950177 | CK QVET | CGS | Substantially Equivalent | |
| K943027 | CHOLESTEROL QVET | CHH | Substantially Equivalent | |
| K943042 | BUN QVET | CDN | Substantially Equivalent | |
| K943001 | MAGNESIUM QVET | JGJ | Substantially Equivalent | |
| K942997 | ALKALINE PHOSPHATASE (ALKP) QVET | CJE | Substantially Equivalent | |
| K942964 | LACTATE DEHYDROGENASE QVET | CFJ | Substantially Equivalent | |
| K942963 | GLUCOSE QVET | CFR | Substantially Equivalent | |
| K944102 | AST QVET | CIT | Substantially Equivalent | |
| K943000 | ALBUMIN QVET | CIX | Substantially Equivalent | |
| K943026 | POTASSIUM QVET | CEJ | Substantially Equivalent | |
| K943004 | TOTAL PROTEIN QVET | CEK | Substantially Equivalent | |
| K943003 | CALCIUM QVET | CJJ | Substantially Equivalent | |
| K942961 | AMYLASE QVET | JFJ | Substantially Equivalent | |
| K942960 | PHOSPHATE QVET | CEO | Substantially Equivalent | |
| K943028 | HDL QVET | LBS | Substantially Equivalent | |
| K943006 | CHLORIDE QVET | CHJ | Substantially Equivalent | |
| K942962 | GGT QVET | JQB | Substantially Equivalent | |
| K943029 | IRON QVET | JIY | Substantially Equivalent | |
| K943002 | URIC ACID QVET | KNK | Substantially Equivalent | |
| K942999 | BILIRUBIN(TOTAL) QVET | CIG | Substantially Equivalent | |
| K944028 | PROCHEM CHEMISTRY ANALYZER | JJE | Substantially Equivalent | |
| K943012 | CALIBRATOR | JIX | Substantially Equivalent | |
| K944080 | ALT QVET | CKA | Substantially Equivalent | |
| K943005 | CREATININE QVET | CGX | Substantially Equivalent | |
| K942998 | TRIGLYCERODES QVET | CDT | Substantially Equivalent | |
| K942949 | BILIRUBIN (DIRECT) QVET | CIG | Substantially Equivalent | |
| K944059 | PROCHEQ 1 & 2 | JJY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JFJCatalytic Methods, Amylase
- CIGDiazo Colorimetry, Bilirubin
- CJJDiazo, Alt/Sgpt
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CFRHexokinase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- CEJTetraphenyl Borate, Colorimetry, Potassium
- CDNUrease, Photometric, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain