Diagnostics 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 13, 2026, FDA's public records list Harleco Diagnostics with 23 510(k) clearances. The most recent is a 510(k) clearance dated Nov 22, 1982: URIC ACID STANDARD, 8MG/DL #65078.
| Nov 22, 1982 | URIC ACID STANDARD, 8MG/DL #65078K823147 · JIS | 510(k) clearances |
| Oct 27, 1982 | TRIGLYCERIDE CALIBRATORK822852 · JIT | 510(k) clearances |
| Sep 2, 1982 | ULTRACHEM BUN-UV, 65080 & 65081K822323 · CDW | 510(k) clearances |
| Jul 14, 1982 | ULTRACHEM CREAK821881 · CGX | 510(k) clearances |
| Jul 14, 1982 | ULTRA CHEM ALBK821880 · CIX | 510(k) clearances |
| Jul 14, 1982 | ULTRAZYME PLUS CK-IK821883 · CGS | 510(k) clearances |
| Jul 14, 1982 | ULTRACHEM URIC ACID AIDHK821872 · CDO | 510(k) clearances |
| Jul 14, 1982 | ULTRAZYME PLUS LDHK821878 · CFJ | 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
