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 A-Kem with 13 510(k) clearances. The most recent is a 510(k) clearance dated Dec 15, 1988: TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS.
| Dec 15, 1988 | TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSK884224 · CIG | 510(k) clearances |
| Dec 9, 1988 | CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMK884227 · JIX | 510(k) clearances |
| Dec 9, 1988 | TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSK884225 · CEK | 510(k) clearances |
| Dec 9, 1988 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMSK884226 · CJA | 510(k) clearances |
| Aug 8, 1988 | A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEMK882587 · CIX | 510(k) clearances |
| Aug 8, 1988 | A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEMK882586 · CIC | 510(k) clearances |
| Oct 23, 1987 | SODIUM/POTASSIUM REAGENT KITK873126 · JGS | 510(k) clearances |
| Oct 23, 1987 | CARBON DIOXIDE REAGENT KITK873129 · JFL | 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
