Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pacific Biotech, Inc. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
139 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924461 | STREP A NEGATIVE CONTROL | Pacific Biotech, Inc. | 1993-12-02 | 456 | 0 |
| K902510 | CARDS O.S. MONO | Pacific Biotech, Inc. | 1990-07-16 | 41 | 0 |
| K896482 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT | Pacific Biotech, Inc. | 1990-03-06 | 113 | 0 |
| K896221 | CARDS O.S.(TM) STREP A | Pacific Biotech, Inc. | 1989-12-13 | 44 | 0 |
| K895390 | CARDS O.S. (TM) HCG-URINE | Pacific Biotech, Inc. | 1989-11-13 | 75 | 0 |
| K891770 | HCG IRMA II | Pacific Biotech, Inc. | 1989-05-24 | 61 | 0 |
| K884616 | FIRSTDAY EARLY PREGNANCY TESTING KIT II | Pacific Biotech, Inc. | 1989-01-13 | 70 | 0 |
| K883742 | MODIFIED TSH IRMA KIT | Pacific Biotech, Inc. | 1989-01-03 | 124 | 0 |
| K884007 | CARDS(TM) MONO | Pacific Biotech, Inc. | 1988-11-18 | 58 | 0 |
| K882895 | MODIFIED BETA QUIK STAT EIA KIT | Pacific Biotech, Inc. | 1988-10-12 | 93 | 0 |
| K883639 | MODIFIED HCG IRMA KIT | Pacific Biotech, Inc. | 1988-10-06 | 42 | 0 |
| K881015 | FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT | Pacific Biotech, Inc. | 1988-08-29 | 172 | 0 |
| K873788 | CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 | Pacific Biotech, Inc. | 1987-11-23 | 67 | 0 |
| K863341 | CARDS(TM) - EARLY PREGNANCY TEST | Pacific Biotech, Inc. | 1987-01-14 | 139 | 0 |
| K863647 | CARDS(TM) STREP A CATALOG NO. CR-7545 | Pacific Biotech, Inc. | 1986-11-26 | 69 | 0 |
| K863199 | CARDS(TM) HCG-URINE | Pacific Biotech, Inc. | 1986-09-15 | 27 | 0 |
| K862007 | HCG IRMA, CAT. NO. CR-1501 | Pacific Biotech, Inc. | 1986-07-01 | 35 | 0 |
| K862249 | TSH IRMA KIT | Pacific Biotech, Inc. | 1986-06-27 | 15 | 0 |
| K861575 | DIRECTATEX STREP A | Pacific Biotech, Inc. | 1986-06-03 | 36 | 0 |
| K860945 | DIRECTACLONE CG SLIDE PREGNANCY TEST | Pacific Biotech, Inc. | 1986-05-02 | 51 | 0 |
| K860965 | BETA QUIK STICK | Pacific Biotech, Inc. | 1986-04-24 | 42 | 0 |
| K852327 | BETA QUIK STAT | Pacific Biotech, Inc. | 1985-08-20 | 82 | 0 |
| K850383 | PRL QUIK RIA KIT | Pacific Biotech, Inc. | 1985-03-01 | 28 | 0 |
| K843795 | BETA QUIK V | Pacific Biotech, Inc. | 1984-10-30 | 33 | 0 |
| K843545 | TSH QUIK RIA KIT | Pacific Biotech, Inc. | 1984-10-02 | 22 | 0 |
| K840230 | FSH QUIK RIA KIT | Pacific Biotech, Inc. | 1984-03-23 | 63 | 0 |
| K840174 | LH QUIK RIA KIT | Pacific Biotech, Inc. | 1984-03-19 | 62 | 0 |
| K831302 | PBI BHCG RIA KIT | Pacific Biotech, Inc. | 1983-06-08 | 48 | 0 |
| K831223 | BETA-QUIK-15 RIA KIT | Pacific Biotech, Inc. | 1983-06-02 | 48 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda