Pacific Biotech, Inc.

FDA 510(k) & PMA Approved Devices — 29 products

Total Devices29

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K924461	STREP A NEGATIVE CONTROL	GTZ	1993-12-02	View
510(k)	K902510	CARDS O.S. MONO	KTN	1990-07-16	View
510(k)	K896482	PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT	LCX	1990-03-06	View
510(k)	K896221	CARDS O.S.(TM) STREP A	GTZ	1989-12-13	View
510(k)	K895390	CARDS O.S. (TM) HCG-URINE	JHI	1989-11-13	View
510(k)	K891770	HCG IRMA II	JHI	1989-05-24	View
510(k)	K884616	FIRSTDAY EARLY PREGNANCY TESTING KIT II	JHI	1989-01-13	View
510(k)	K883742	MODIFIED TSH IRMA KIT	JLW	1989-01-03	View
510(k)	K884007	CARDS(TM) MONO	KTN	1988-11-18	View
510(k)	K882895	MODIFIED BETA QUIK STAT EIA KIT	DHA	1988-10-12	View
510(k)	K883639	MODIFIED HCG IRMA KIT	JHI	1988-10-06	View
510(k)	K881015	FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT	JHI	1988-08-29	View
510(k)	K873788	CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504	JHI	1987-11-23	View
510(k)	K863341	CARDS(TM) - EARLY PREGNANCY TEST	LCX	1987-01-14	View
510(k)	K863647	CARDS(TM) STREP A CATALOG NO. CR-7545	GTZ	1986-11-26	View
510(k)	K863199	CARDS(TM) HCG-URINE	JHI	1986-09-15	View
510(k)	K862007	HCG IRMA, CAT. NO. CR-1501	JHI	1986-07-01	View
510(k)	K862249	TSH IRMA KIT	JLW	1986-06-27	View
510(k)	K861575	DIRECTATEX STREP A	GTY	1986-06-03	View
510(k)	K860945	DIRECTACLONE CG SLIDE PREGNANCY TEST	JHJ	1986-05-02	View