Company ยท US
Pacific Biotech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1993. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 13 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 |
| KTN | System, Test, Infectious Mononucleosis | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 2, 1993 | K924461 | STREP A NEGATIVE CONTROL Pacific Biotech, Inc. | GTZ |
| Jul 16, 1990 | K902510 | CARDS O.S. MONO Pacific Biotech, Inc. | KTN |
| Mar 6, 1990 | K896482 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT Pacific Biotech, Inc. | LCX |
| Dec 13, 1989 | K896221 | CARDS O.S.(TM) STREP A Pacific Biotech, Inc. | GTZ |
| Nov 13, 1989 | K895390 | CARDS O.S. (TM) HCG-URINE Pacific Biotech, Inc. | JHI |
| May 24, 1989 | K891770 | HCG IRMA II Pacific Biotech, Inc. | JHI |
| Jan 13, 1989 | K884616 | FIRSTDAY EARLY PREGNANCY TESTING KIT II Pacific Biotech, Inc. | JHI |
| Jan 3, 1989 | K883742 | MODIFIED TSH IRMA KIT Pacific Biotech, Inc. | JLW |
| Nov 18, 1988 | K884007 | CARDS(TM) MONO Pacific Biotech, Inc. | KTN |
| Oct 12, 1988 | K882895 | MODIFIED BETA QUIK STAT EIA KIT Pacific Biotech, Inc. | DHA |
| Oct 6, 1988 | K883639 | MODIFIED HCG IRMA KIT Pacific Biotech, Inc. | JHI |
| Aug 29, 1988 | K881015 | FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT Pacific Biotech, Inc. | JHI |
| Nov 23, 1987 | K873788 | CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 Pacific Biotech, Inc. | JHI |
| Jan 14, 1987 | K863341 | CARDS(TM) - EARLY PREGNANCY TEST Pacific Biotech, Inc. | LCX |
| Nov 26, 1986 | K863647 | CARDS(TM) STREP A CATALOG NO. CR-7545 Pacific Biotech, Inc. | GTZ |
| Sep 15, 1986 | K863199 | CARDS(TM) HCG-URINE Pacific Biotech, Inc. | JHI |
| Jul 1, 1986 | K862007 | HCG IRMA, CAT. NO. CR-1501 Pacific Biotech, Inc. | JHI |
| Jun 27, 1986 | K862249 | TSH IRMA KIT Pacific Biotech, Inc. | JLW |
| Jun 3, 1986 | K861575 | DIRECTATEX STREP A Pacific Biotech, Inc. | GTY |
| May 2, 1986 | K860945 | DIRECTACLONE CG SLIDE PREGNANCY TEST Pacific Biotech, Inc. | JHJ |
| Apr 24, 1986 | K860965 | BETA QUIK STICK Pacific Biotech, Inc. | JHI |
| Aug 20, 1985 | K852327 | BETA QUIK STAT Pacific Biotech, Inc. | JHI |
| Mar 1, 1985 | K850383 | PRL QUIK RIA KIT Pacific Biotech, Inc. | CFT |
| Oct 30, 1984 | K843795 | BETA QUIK V Pacific Biotech, Inc. | JHI |
| Oct 2, 1984 | K843545 | TSH QUIK RIA KIT Pacific Biotech, Inc. | JLW |
| Mar 23, 1984 | K840230 | FSH QUIK RIA KIT Pacific Biotech, Inc. | CGJ |
| Mar 19, 1984 | K840174 | LH QUIK RIA KIT Pacific Biotech, Inc. | CEP |
| Jun 8, 1983 | K831302 | PBI BHCG RIA KIT Pacific Biotech, Inc. | JHI |
| Jun 2, 1983 | K831223 | BETA-QUIK-15 RIA KIT Pacific Biotech, Inc. | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||