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 14, 2026, FDA's public records list PB Diagnostic Systems, Inc. with 35 510(k) clearances. The most recent is a 510(k) clearance dated Jul 28, 1994: OPUS FT4 TEST SYSTEM.
| Jul 28, 1994 | OPUS FT4 TEST SYSTEMK940507 · CEC | 510(k) clearances |
| Jul 20, 1994 | OPUS PROCAINAMIDE TEST SYSTEMK934762 · LAR | 510(k) clearances |
| Jun 28, 1994 | OPUS CMV-GK933389 · LFZ | 510(k) clearances |
| Mar 7, 1994 | OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK934137 · MJX | 510(k) clearances |
| Dec 22, 1993 | OPUS DIGITOXINK935229 · DPG | 510(k) clearances |
| Nov 22, 1993 | OPUS NAPAK934705 · LAN | 510(k) clearances |
| Sep 8, 1993 | OPUS ESTRADIOLK933066 · CHP | 510(k) clearances |
| Sep 8, 1993 | OPUS TOTAL CKK933675 · CGS | 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
