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 Hi-Chem with 52 510(k) clearances. The most recent is a 510(k) clearance dated Apr 4, 1996: HICHEM GLUCOSE/HK REAGENT KIT.
| Apr 4, 1996 | HICHEM GLUCOSE/HK REAGENT KITK960084 · CFR | 510(k) clearances |
| May 15, 1995 | HICHEM ALT REAGENT KITK951818 · CKA | 510(k) clearances |
| Oct 4, 1994 | HICHEM ENZYME VERIFIER KITK943684 · JJT | 510(k) clearances |
| May 13, 1994 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K941764 · CJY | 510(k) clearances |
| Jul 17, 1990 | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDK902673 · JJY | 510(k) clearances |
| Oct 24, 1986 | ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)K863617 · JGS | 510(k) clearances |
| Jun 13, 1986 | LDP REAGENT CARTRIDGE (NO. 88216)K862027 · CFJ | 510(k) clearances |
| Jun 5, 1986 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)K861893 · JXL | 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
