Pb Diagnostic Systems, Inc.

FDA 510(k) & PMA Approved Devices — 35 products

Total Devices35

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K940507	OPUS FT4 TEST SYSTEM	CEC	1994-07-28	View
510(k)	K934762	OPUS PROCAINAMIDE TEST SYSTEM	LAR	1994-07-20	View
510(k)	K933389	OPUS CMV-G	LFZ	1994-06-28	View
510(k)	K934137	OPUS(R) SEROLOGY CONTROLS, MODIFICATION	MJX	1994-03-07	View
510(k)	K935229	OPUS DIGITOXIN	DPG	1993-12-22	View
510(k)	K934705	OPUS NAPA	LAN	1993-11-22	View
510(k)	K933675	OPUS TOTAL CK	CGS	1993-09-08	View
510(k)	K933066	OPUS ESTRADIOL	CHP	1993-09-08	View
510(k)	K932279	OPUS(R) TOTAL B-HCG TEST SYSTEM	JHI	1993-07-08	View
510(k)	K926131	OPUS MAGNUM ANALYZER	KHO	1993-06-07	View
510(k)	K924957	OPUS(R) VANCOMYCIN	LEH	1992-12-11	View
510(k)	K924429	OPUS(R) CK-MB	JHY	1992-10-15	View
510(k)	K915838	OPUS FERRITIN TEST SYSTEM	DGE	1992-03-18	View
510(k)	K915850	OPUS MYOGLOBIN TEST SYSTEM	DDR	1992-03-17	View
510(k)	K913938	OPUS(R) LH TEST SYSTEM	CEP	1991-11-07	View
510(k)	K913295	OPUS(R) PLUS ANALYZER	JJQ	1991-09-11	View
510(k)	K913280	OPUS(R) PROLACTIN TEST SYSTEM	CFT	1991-08-16	View
510(k)	K911834	OPUS(R) ROZO	LGD	1991-08-12	View
510(k)	K911940	OPUS(R) TOBRAMYCIN	LCR	1991-07-01	View
510(k)	K905257	OPUS CMV TEST SYSTEM	LIN	1991-04-17	View