Prisma Systems
Medical device manufacturer in Rome, NY.
27510(k) clearances
0PMA approvals
0recalls
Device types
- CIG Diazo Colorimetry, Bilirubin 2
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- CFR Hexokinase, Glucose 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- CEJ Tetraphenyl Borate, Colorimetry, Potassium 1
- CEK Biuret (Colorimetric), Total Protein 1
- CJJ Diazo, Alt/Sgpt 1
- JFJ Catalytic Methods, Amylase 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- CHJ Mercuric Thiocyanate, Colorimetry, Chloride 1
- JQB Kinetic Method, Gamma-Glutamyl Transpeptidase 1
- JIY Photometric Method, Iron (Non-Heme) 1
- KNK Acid, Uric, Uricase (Colorimetric) 1
- JJE Analyzer, Chemistry (Photometric… 1
- JIX Calibrator, Multi-Analyte Mixture 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K950177 | CK QvetCGS · Traditional | 03/03/1995SE |
| K943027 | Cholesterol QvetCHH · Traditional | 01/27/1995SE |
| K943042 | Bun QvetCDN · Traditional | 12/29/1994SE |
| K943001 | Magnesium QvetJGJ · Traditional | 12/29/1994SE |
| K942997 | Alkaline Phosphatase (Alkp) QvetCJE · Traditional | 12/29/1994SE |
| K942964 | Lactate Dehydrogenase QvetCFJ · Traditional | 12/29/1994SE |
| K942963 | Glucose QvetCFR · Traditional | 12/29/1994SE |
| K944102 | Ast QvetCIT · Traditional | 12/13/1994SE |
| K943000 | Albumin QvetCIX · Traditional | 12/13/1994SE |
| K943026 | Potassium QvetCEJ · Traditional | 12/09/1994SE |
| K943004 | Total Protein QvetCEK · Traditional | 12/09/1994SE |
| K943003 | Calcium QvetCJJ · Traditional | 12/09/1994SE |
| K942961 | Amylase QvetJFJ · Traditional | 12/09/1994SE |
| K942960 | Phosphate QvetCEO · Traditional | 12/09/1994SE |
| K943028 | HDL QvetLBS · Traditional | 12/07/1994SE |
| K943006 | Chloride QvetCHJ · Traditional | 12/07/1994SE |
| K942962 | GGT QvetJQB · Traditional | 12/07/1994SE |
| K943029 | Iron QvetJIY · Traditional | 12/02/1994SE |
| K943002 | Uric Acid QvetKNK · Traditional | 12/02/1994SE |
| K942999 | Bilirubin(Total) QvetCIG · Traditional | 12/02/1994SE |
| K944028 | Prochem Chemistry AnalyzerJJE · Traditional | 11/30/1994SE |
| K943012 | CalibratorJIX · Traditional | 11/28/1994SE |
| K944080 | Alt QvetCKA · Traditional | 11/22/1994SE |
| K943005 | Creatinine QvetCGX · Traditional | 11/22/1994SE |
| K942998 | Triglycerodes QvetCDT · Traditional | 11/22/1994SE |
| K942949 | Bilirubin (Direct) QvetCIG · Traditional | 11/22/1994SE |
| K944059 | Procheq 1 & 2JJY · Traditional | 11/15/1994SE |