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Company · US

Thermo Biostar, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2004. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

2recalls (0 in 12 months)

2recalls that name a 510(k)

Product codes

Code	Device	Records
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	3
GOG	Antisera, Cf, Poliovirus 1-3	1
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	1
LIR	Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae	1
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Mar 2, 2004	K032330	CT OIA Thermo Biostar, Inc.	LJC
Apr 17, 2003	K023947	GC OIA Thermo Biostar, Inc.	LIR
Mar 27, 2003	K023556	FLU OIA A/B TEST KIT Thermo Biostar, Inc.	PSZ
Jan 14, 2003	K023779	RSV OIA Thermo Biostar, Inc.	GQG
Sep 13, 2002	K021172	RSV OIA Thermo Biostar, Inc.	GOG

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Mar 6, 2003	Thermo Biostar, Incorporated Chlamydia OIA. For in vitro diagnostic use. Terminated	LJC	K951010
Mar 6, 2003	Thermo Biostar, Incorporated Chlamydia OIA. For in vitro diagnostic use, Terminated	LJC	K951010

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