Company · US

Biostar, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1999. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
GTY	Antigens, All Groups, Streptococcus Spp.	2
GTZ	Antisera, All Groups, Streptococcus Spp.	1
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	1
LLH	Reagents, Clostridium Difficile Toxin	1
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	1

Decided	510(k)	Device and applicant	Code
Nov 2, 1999	K991829	CDTOX A OIA Biostar, Inc.	LLH
Aug 19, 1999	K991828	STREP B OIA Biostar, Inc.	GTY
Nov 25, 1998	K981651	AB FLU OIA Biostar, Inc.	PSZ
Jul 23, 1997	K962060	STREP A OIA MAX Biostar, Inc.	GTZ
Oct 7, 1995	K951010	CHLAMYDIA OIA Biostar, Inc.	LJC
Jul 6, 1994	K936112	STREP B OIA Biostar, Inc.	GTY

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.