Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Pro-Lab Diagnostics with 32 510(k) clearances. The most recent is a 510(k) clearance dated Jan 27, 1995: PROLEX (STREPTOCCAL GROUPING LATEX KIT).
| Jan 27, 1995 | PROLEX (STREPTOCCAL GROUPING LATEX KIT)K934383 · GTZ | 510(k) clearances |
| Dec 15, 1994 | E.COLI 0157 LATEX TESTK944421 · GMZ | 510(k) clearances |
| Sep 1, 1993 | AMNIOTEST(TM)K914419 · HIO | 510(k) clearances |
| Dec 24, 1992 | TRANSYSTEM LIQUID STUART MEDIUMK924331 · LIO | 510(k) clearances |
| Dec 24, 1992 | TRANSYSTEM AMIES W/O CHARCOALK924329 · LIO | 510(k) clearances |
| Dec 24, 1992 | TRANSYSTEM AMIES WITH CHARCOALK924330 · LIO | 510(k) clearances |
| Dec 24, 1992 | TRANSYSTEM LIQUID AMIES MEDIUMK924328 · LIO | 510(k) clearances |
| Jul 28, 1992 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYK921421 · LHL | 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
