Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Sterling Biochemical, Inc. with 15 510(k) clearances. The most recent is a 510(k) clearance dated Jan 18, 1985: GLUCOSE(HEXOKINASE) REAGENT SET.
| Jan 18, 1985 | GLUCOSE(HEXOKINASE) REAGENT SETK844998 · CFR | 510(k) clearances |
| Jan 8, 1985 | ALT/GPT REAGENT SETK844251 · CKA | 510(k) clearances |
| Sep 14, 1984 | ALKALINE PHOSPHATASE REAGENT SETK843332 · CJE | 510(k) clearances |
| Aug 12, 1984 | AST/GOT REAGENT SET UV RATEK842521 · CIT | 510(k) clearances |
| Jun 14, 1984 | UREA NITROGEN REAGENT SETK840064 · CDQ | 510(k) clearances |
| Feb 4, 1984 | HYDROXYBUTYRATE DEHYDROGENASE REAGENTK834084 · JKF | 510(k) clearances |
| Jan 30, 1984 | URIC ACID REAGENT SETK834045 · KNK | 510(k) clearances |
| Jan 13, 1984 | AMYLASE REAGENT SET-MODIFIED CARAWAYK833864 · CJA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
