Medical device 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 Pacific Biotech, Inc. with 29 510(k) clearances. The most recent is a 510(k) clearance dated Dec 2, 1993: STREP A NEGATIVE CONTROL.
| Dec 2, 1993 | STREP A NEGATIVE CONTROLK924461 · GTZ | 510(k) clearances |
| Jul 16, 1990 | CARDS O.S. MONOK902510 · KTN | 510(k) clearances |
| Mar 6, 1990 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KITK896482 · LCX | 510(k) clearances |
| Dec 13, 1989 | CARDS O.S.(TM) STREP AK896221 · GTZ | 510(k) clearances |
| Nov 13, 1989 | CARDS O.S. (TM) HCG-URINEK895390 · JHI | 510(k) clearances |
| May 24, 1989 | HCG IRMA IIK891770 · JHI | 510(k) clearances |
| Jan 13, 1989 | FIRSTDAY EARLY PREGNANCY TESTING KIT IIK884616 · JHI | 510(k) clearances |
| Jan 3, 1989 | MODIFIED TSH IRMA KITK883742 · JLW | 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
