Medical device 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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list OPTI Medical Systems with 3 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Aug 2, 2021: OPTI® B-Lac Cassette.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 2, 2021 | OPTI® B-Lac CassetteK200986 · CHL | 510(k) clearances |
| Jun 25, 2021 | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004Class II · The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to | Device recalls |
| Aug 22, 2013 | OPTI CCA-TS2K131126 · CHL | 510(k) clearances |
| Aug 9, 2013 | Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION ElectClass II · OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance o | Device recalls |
| Jul 3, 2012 | BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitrClass II · The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 28 | Device recalls |
| Jan 7, 2011 | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561K093280 · CHL | 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
