Company ยท US
Worthington Biochemical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1978. Name variants (Inc, Corp, punctuation) are merged.
13510(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.) | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| JIT | Calibrator, Secondary | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CEX | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| JIS | Calibrator, Primary | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 19, 1978 | K780389 | HDL REAGENT SET FOR LIPOPROTEINS Worthington Biochemical Corp. | CHH |
| Mar 3, 1978 | K780096 | LDH ISOENZYME CONTROL SERUM Worthington Biochemical Corp. | JJY |
| Jan 24, 1978 | K772356 | LDH ISOENZYME COLUMN REAGENT SET Worthington Biochemical Corp. | CEX |
| Nov 11, 1977 | K772025 | URIC ACID STD. FOR QUANT. URIC ACID Worthington Biochemical Corp. | JIS |
| Jul 11, 1977 | K771143 | INORGANIC PHOSPHORUS STANDARDS Worthington Biochemical Corp. | JIT |
| Jul 11, 1977 | K771001 | STATZYME GLUCOSE Worthington Biochemical Corp. | CGA |
| Jul 11, 1977 | K770831 | STATZYME URIC ACID REAGENT Worthington Biochemical Corp. | CDO |
| Jun 2, 1977 | K770470 | WORTHINGTON BUN Worthington Biochemical Corp. | CDW |
| Mar 1, 1977 | K770277 | CHOLESTEROL STANDARDS Worthington Biochemical Corp. | JIT |
| Dec 29, 1976 | K761263 | CHOLESTEROL AUTOMATED REAGENT Worthington Biochemical Corp. | CHH |
| Dec 29, 1976 | K761262 | TRIGLYCERIDES (LIPASE) REAGENT SET Worthington Biochemical Corp. | CDT |
| Dec 9, 1976 | K760989 | URIC ACID REAGENT SET Worthington Biochemical Corp. | CDO |
| Nov 16, 1976 | K760990 | INORGANIC PHOSPHOROUS REAGENT Worthington Biochemical Corp. | CEO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||