Diagnostic Solutions, Inc.
Medical device manufacturer in Irvine, CA.
26510(k) clearances
0PMA approvals
0recalls
Device types
- CGA Glucose Oxidase, Glucose 4
- CIG Diazo Colorimetry, Bilirubin 2
- CHJ Mercuric Thiocyanate, Colorimetry, Chloride 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- KMS Phenolphthalein Colorimetry, Carbon-Dioxide 1
- CEM Electrode, Ion Specific, Potassium 1
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- JHY Colorimetric Method, Cpk Or Isoenzymes 1
- CDH Acid, Uric, Phosphotungstate Reduction 1
- CGO Lieberman-Burchard/Abell-Kendall… 1
- CIC Cresolphthalein Complexone, Calcium 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- JIY Photometric Method, Iron (Non-Heme) 1
- JGS Electrode, Ion Specific, Sodium 1
- CEK Biuret (Colorimetric), Total Protein 1
- CDW Diacetyl-Monoxime, Urea Nitrogen 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K934892 | Relief Plus One Reagent Strip ModificationCGA · Traditional | 01/11/1994SE |
| K924398 | Uni-Check Reagent StripCGA · Traditional | 12/23/1992SE |
| K921825 | Quick-Check II Reagent StripCGA · Traditional | 08/18/1992SE |
| K800689 | Reagent for Determ. Glutamic-Pyruvic-CKA · Traditional | 05/30/1980SE |
| K800681 | Reagents for Determ. CO2 in Human SerumKMS · Traditional | 05/30/1980SE |
| K800692 | Reagent for Determ. Potassium/In HumanCEM · Traditional | 05/28/1980SE |
| K800691 | Reagent for Determ. Lactate/DehydrogenasCFJ · Traditional | 05/28/1980SE |
| K800690 | Reagent for Determ. Inorganic/PhosphorusCEO · Traditional | 05/28/1980SE |
| K800688 | Reagent for Determ. Glutamic-OxaloaceticCIT · Traditional | 05/28/1980SE |
| K800687 | Reagent for Determ. Glucose in H/SerumCGA · Traditional | 05/28/1980SE |
| K800686 | Reagent for Determ. Direct BilirubinCIG · Traditional | 05/28/1980SE |
| K800685 | Reagent for Determ. Creatinine in H/SeruCGX · Traditional | 05/28/1980SE |
| K800684 | Reagent for Determ. Creatine PhosphokinaJHY · Traditional | 05/28/1980SE |
| K800683 | Reagent for Determ. Chloride in Human/SmCHJ · Traditional | 05/28/1980SE |
| K800682 | Reagents for Determ. Cholesterol/SerumCGO · Traditional | 05/28/1980SE |
| K800680 | Reagents for Determ. Calcium in HumanCIC · Traditional | 05/28/1980SE |
| K800679 | Reagents for Determ. Alkaline PhosphatasCJE · Traditional | 05/28/1980SE |
| K800678 | Reagents for Determ. Albumin in HumanCIX · Traditional | 05/28/1980SE |
| K800677 | Reagents for Determ. Serum Iron in HumanJIY · Traditional | 05/28/1980SE |
| K800676 | Reagents for Determ. Sodium in Human SumJGS · Traditional | 05/28/1980SE |
| K800675 | Reagents for Determ. Total BilirubinCIG · Traditional | 05/28/1980SE |
| K800674 | Smac Replacement/Total Protein Human SerCEK · Traditional | 05/28/1980SE |
| K800673 | Smac Replacement Reagents/Of Bun-SerumCDW · Traditional | 05/28/1980SE |
| K800672 | Smac Replacement Reagents/Determ-Uric-AcCDH · Traditional | 05/28/1980SE |
| K800671 | Smac Replacement Reagents-Wash Solutions · Traditional | 04/16/1980SE |
| K800670 | Smac Replacement Reagents, Wetting Agent · Traditional | 04/16/1980SE |