Pacific Biotech, Inc.
Medical device manufacturer in San Diego, CA.
29510(k) clearances
0PMA approvals
0recalls
Device types
- JHI Visual, Pregnancy Hcg, Prescription Use 13
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 3
- GTZ Antisera, All Groups, Streptococcus Spp. 3
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 2
- KTN System, Test, Infectious Mononucleosis 2
- CEP Radioimmunoassay, Luteinizing Hormone 1
- CGJ Radioimmunoassay, Follicle-Stimulating… 1
- CFT Radioimmunoassay, Prolactin (Lactogen) 1
- JHJ Agglutination Method, Human Chorionic… 1
- GTY Antigens, All Groups, Streptococcus Spp. 1
- DHA System, Test, Human Chorionic Gonadotropin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K924461 | Strep a Negative ControlGTZ · Traditional | 12/02/1993SE |
| K902510 | Cards O.S. MonoKTN · Traditional | 07/16/1990SE |
| K896482 | Perfect(Tm) One Step Early Pregnancy Test KitLCX · Traditional | 03/06/1990SE |
| K896221 | Cards O.S.(Tm) Strep aGTZ · Traditional | 12/13/1989SE |
| K895390 | Cards O.S. (TM) Hcg-UrineJHI · Traditional | 11/13/1989SE |
| K891770 | HCG Irma IIJHI · Traditional | 05/24/1989SE |
| K884616 | Firstday Early Pregnancy Testing Kit IIJHI · Traditional | 01/13/1989SE |
| K883742 | Modified TSH Irma KitJLW · Traditional | 01/03/1989SE |
| K884007 | Cards(Tm) MonoKTN · Traditional | 11/18/1988SE |
| K882895 | Modified Beta Quik Stat Eia KitDHA · Traditional | 10/12/1988SE |
| K883639 | Modified HCG Irma KitJHI · Traditional | 10/06/1988SE |
| K881015 | Firstday(Tm) Early Pregnancy Testing KitJHI · Traditional | 08/29/1988SE |
| K873788 | Cards(Tm) Hcg-Serum/Urine CR-7503 and CR-7504JHI · Traditional | 11/23/1987SE |
| K863341 | Cards(Tm) - Early Pregnancy TestLCX · Traditional | 01/14/1987SE |
| K863647 | Cards(Tm) Strep a Catalog No. CR-7545GTZ · Traditional | 11/26/1986SE |
| K863199 | Cards(Tm) Hcg-UrineJHI · Traditional | 09/15/1986SE |
| K862007 | HCG Irma, Cat. No. CR-1501JHI · Traditional | 07/01/1986SE |
| K862249 | TSH Irma KitJLW · Traditional | 06/27/1986SE |
| K861575 | Directatex Strep aGTY · Traditional | 06/03/1986SE |
| K860945 | Directaclone CG Slide Pregnancy TestJHJ · Traditional | 05/02/1986SE |
| K860965 | Beta Quik StickJHI · Traditional | 04/24/1986SE |
| K852327 | Beta Quik StatJHI · Traditional | 08/20/1985SE |
| K850383 | PRL Quik Ria KitCFT · Traditional | 03/01/1985SE |
| K843795 | Beta Quik VJHI · Traditional | 10/30/1984SE |
| K843545 | TSH Quik Ria KitJLW · Traditional | 10/02/1984SE |
| K840230 | FSH Quik Ria KitCGJ · Traditional | 03/23/1984SE |
| K840174 | LH Quik Ria KitCEP · Traditional | 03/19/1984SE |
| K831302 | Pbi BHCG Ria KitJHI · Traditional | 06/08/1983SE |
| K831223 | BETA-QUIK-15 Ria KitJHI · Traditional | 06/02/1983SE |