Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of BayerLabelled 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. See the Bayer group view.
As of Nov 14, 2026, FDA's public records list Miles Laboratories with 158 510(k) clearances. The most recent is a 510(k) clearance dated May 26, 1988: LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER.
| May 26, 1988 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK880605 · FPB | 510(k) clearances |
| Apr 28, 1988 | MICRO-BUMINTEST REAGENT TABLETSK874909 · JIR | 510(k) clearances |
| Apr 5, 1988 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK875079 · CKA | 510(k) clearances |
| Dec 22, 1987 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK871835 · CGA | 510(k) clearances |
| Oct 28, 1987 | SERALYZER III BLOOD CHEMISTRY ANALYZERK872120 · JJF | 510(k) clearances |
| Sep 11, 1987 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)K873304 · LJX | 510(k) clearances |
| Aug 4, 1987 | CUTTER PUREFLO PLUS IV FILTERK872634 · FPB | 510(k) clearances |
| Jun 29, 1987 | MODIFIED SALTEX REAGENT STRIPSK870214 · CHK | 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
