Company ยท US
Biorent Diagnostic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1983. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDO | Acid, Uric, Uricase (U.V.) | 1 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 1983 | K832747 | ALBUMIN REAGENT SET Biorent Diagnostic, Inc. | CIX |
| Nov 22, 1982 | K823211 | CK-UV REAGENT Biorent Diagnostic, Inc. | JHS |
| Nov 22, 1982 | K823060 | HEMOGLOBIN REAGENT Biorent Diagnostic, Inc. | KHG |
| Sep 21, 1982 | K822494 | OPTIMIZED UV-GPT REAGENT SET Biorent Diagnostic, Inc. | CKA |
| Sep 21, 1982 | K822493 | OPTIMIZED UV-GOT REAGENT SET Biorent Diagnostic, Inc. | CIT |
| Sep 17, 1982 | K822492 | OPTIMIZED UV-LDH REAGENT SET Biorent Diagnostic, Inc. | CFJ |
| Apr 14, 1982 | K820768 | COLORIMETRIC LDH REAGENT SET Biorent Diagnostic, Inc. | CFH |
| Mar 25, 1982 | K820632 | COLORIMETRIC URIC ACID REAGENT SET Biorent Diagnostic, Inc. | KNK |
| Jan 18, 1982 | K813555 | GLUCOSE ENZYME-COLOR REAGENT SET Biorent Diagnostic, Inc. | CGA |
| Dec 8, 1981 | K813244 | UV URIC ACID DETERMINATION Biorent Diagnostic, Inc. | CDO |
| Jul 10, 1981 | K811760 | CHOLESTEROL DETERMINATION Biorent Diagnostic, Inc. | CHH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||