Pacific Biotech, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Pacific Biotech, Inc.” (first 1983, latest 1993), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 13 | 13 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 | 3 |
| KTN | System, Test, Infectious Mononucleosis | 2 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (23)
- Microbiology (6)
Most recent Pacific Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924461 | STREP A NEGATIVE CONTROL | GTZ | 1993-12-02 | 456 |
| K902510 | CARDS O.S. MONO | KTN | 1990-07-16 | 41 |
| K896482 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT | LCX | 1990-03-06 | 113 |
| K896221 | CARDS O.S.(TM) STREP A | GTZ | 1989-12-13 | 44 |
| K895390 | CARDS O.S. (TM) HCG-URINE | JHI | 1989-11-13 | 75 |
| K891770 | HCG IRMA II | JHI | 1989-05-24 | 61 |
| K884616 | FIRSTDAY EARLY PREGNANCY TESTING KIT II | JHI | 1989-01-13 | 70 |
| K883742 | MODIFIED TSH IRMA KIT | JLW | 1989-01-03 | 124 |
| K884007 | CARDS(TM) MONO | KTN | 1988-11-18 | 58 |
| K882895 | MODIFIED BETA QUIK STAT EIA KIT | DHA | 1988-10-12 | 93 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pacific Biotech, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pacific Hemostasis (29 510(k)s)
- Pacific Dental Corp. (22 510(k)s)
- Pacific Device, Inc. (5 510(k)s)
- Pacific Union Dental, Inc. (5 510(k)s)
- Pacific Consolidated Industries, LLC (4 510(k)s)
- Pacific Materials and Interfaces (3 510(k)s)
- Pacific Andrology, Inc. (2 510(k)s)
- Pacific Consolidated Industries Llp (2 510(k)s)
- Pacific Delta Medical Supply (2 510(k)s)
- Pacific Implant, Inc. (2 510(k)s)
- Pacific Medico Co., Ltd. (2 510(k)s)
- Pacific Rim Dental, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pacific Biotech, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Pacific Biotech, Inc.” (first 1983, latest 1993), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pacific Biotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pacific Biotech, Inc. is 58 days.
Which FDA product codes appear under Pacific Biotech, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 13); GTZ (Antisera, All Groups, Streptococcus Spp., 3); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 3).
Next steps
- See all 29 Pacific Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Pacific Biotech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.