Company ยท US
Diagnostic Solutions, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1994. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CGA | Glucose Oxidase, Glucose | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 |
| KMS | Phenolphthalein Colorimetry, Carbon-Dioxide | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 1994 | K934892 | RELIEF PLUS ONE REAGENT STRIP MODIFICATION Diagnostic Solutions, Inc. | CGA |
| Dec 23, 1992 | K924398 | UNI-CHECK REAGENT STRIP Diagnostic Solutions, Inc. | CGA |
| Aug 18, 1992 | K921825 | QUICK-CHECK II REAGENT STRIP Diagnostic Solutions, Inc. | CGA |
| May 30, 1980 | K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- Diagnostic Solutions, Inc. | CKA |
| May 30, 1980 | K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM Diagnostic Solutions, Inc. | KMS |
| May 28, 1980 | K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN Diagnostic Solutions, Inc. | CEM |
| May 28, 1980 | K800691 | REAGENT FOR DETERM. LACTATE/DEHYDROGENAS Diagnostic Solutions, Inc. | CFJ |
| May 28, 1980 | K800690 | REAGENT FOR DETERM. INORGANIC/PHOSPHORUS Diagnostic Solutions, Inc. | CEO |
| May 28, 1980 | K800688 | REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC Diagnostic Solutions, Inc. | CIT |
| May 28, 1980 | K800687 | REAGENT FOR DETERM. GLUCOSE IN H/SERUM Diagnostic Solutions, Inc. | CGA |
| May 28, 1980 | K800686 | REAGENT FOR DETERM. DIRECT BILIRUBIN Diagnostic Solutions, Inc. | CIG |
| May 28, 1980 | K800685 | REAGENT FOR DETERM. CREATININE IN H/SERU Diagnostic Solutions, Inc. | CGX |
| May 28, 1980 | K800684 | REAGENT FOR DETERM. CREATINE PHOSPHOKINA Diagnostic Solutions, Inc. | JHY |
| May 28, 1980 | K800683 | REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM Diagnostic Solutions, Inc. | CHJ |
| May 28, 1980 | K800682 | REAGENTS FOR DETERM. CHOLESTEROL/SERUM Diagnostic Solutions, Inc. | CGO |
| May 28, 1980 | K800680 | REAGENTS FOR DETERM. CALCIUM IN HUMAN Diagnostic Solutions, Inc. | CIC |
| May 28, 1980 | K800679 | REAGENTS FOR DETERM. ALKALINE PHOSPHATAS Diagnostic Solutions, Inc. | CJE |
| May 28, 1980 | K800678 | REAGENTS FOR DETERM. ALBUMIN IN HUMAN Diagnostic Solutions, Inc. | CIX |
| May 28, 1980 | K800677 | REAGENTS FOR DETERM. SERUM IRON IN HUMAN Diagnostic Solutions, Inc. | JIY |
| May 28, 1980 | K800676 | REAGENTS FOR DETERM. SODIUM IN HUMAN SUM Diagnostic Solutions, Inc. | JGS |
| May 28, 1980 | K800675 | REAGENTS FOR DETERM. TOTAL BILIRUBIN Diagnostic Solutions, Inc. | CIG |
| May 28, 1980 | K800674 | SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER Diagnostic Solutions, Inc. | CEK |
| May 28, 1980 | K800673 | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM Diagnostic Solutions, Inc. | CDW |
| May 28, 1980 | K800672 | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC Diagnostic Solutions, Inc. | CDH |
| Apr 16, 1980 | K800671 | SMAC REPLACEMENT REAGENTS-WASH SOLUTIONS Diagnostic Solutions, Inc. | |
| Apr 16, 1980 | K800670 | SMAC REPLACEMENT REAGENTS, WETTING AGENT Diagnostic Solutions, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||