Worthington Biochemical Corp.
Mchenry, IL, US
Worthington Biochemical Corp. appears in FDA device records in Mchenry, IL. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Worthington Biochemical Corp. between 1976 and 1978. The busiest year on record is 1977, with 6. The most recent is 1978, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 6 |
| 1978 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K780389 | HDL REAGENT SET FOR LIPOPROTEINS | CHH | Substantially Equivalent | |
| K780096 | LDH ISOENZYME CONTROL SERUM | JJY | Substantially Equivalent | |
| K772356 | LDH ISOENZYME COLUMN REAGENT SET | CEX | Substantially Equivalent | |
| K772025 | URIC ACID STD. FOR QUANT. URIC ACID | JIS | Substantially Equivalent | |
| K771143 | INORGANIC PHOSPHORUS STANDARDS | JIT | Substantially Equivalent | |
| K771001 | STATZYME GLUCOSE | CGA | Substantially Equivalent | |
| K770831 | STATZYME URIC ACID REAGENT | CDO | Substantially Equivalent | |
| K770470 | WORTHINGTON BUN | CDW | Substantially Equivalent | |
| K770277 | CHOLESTEROL STANDARDS | JIT | Substantially Equivalent | |
| K761263 | CHOLESTEROL AUTOMATED REAGENT | CHH | Substantially Equivalent | |
| K761262 | TRIGLYCERIDES (LIPASE) REAGENT SET | CDT | Substantially Equivalent | |
| K760989 | URIC ACID REAGENT SET | CDO | Substantially Equivalent | |
| K760990 | INORGANIC PHOSPHOROUS REAGENT | CEO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDOAcid, Uric, Uricase (U.V.)
- JISCalibrator, Primary
- JITCalibrator, Secondary
- CEXChromatographic Separation, Lactate Dehydrogenase Isoenzymes
- CDWDiacetyl-Monoxime, Urea Nitrogen
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CGAGlucose Oxidase, Glucose
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain