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Company · US

Virion (U.S.), Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1994. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
GMN	Antigens, Cf, Toxoplasma Gondii	1
GNG	Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6	1
GQS	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	1
GRC	Antigen, Cf (Including Cf Control), Mumps Virus	1
MCD	Antigen, Ebv, Capsid	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jun 13, 1994	K933251	EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST Virion (U.S.), Inc.	MCD
Jun 29, 1992	K921618	COXSACKIE VIRUS B1-B6 CF ANTIGENS Virion (U.S.), Inc.	GNG
Jun 17, 1991	K905306	MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN Virion (U.S.), Inc.	GRC
Mar 21, 1991	K905385	P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN Virion (U.S.), Inc.	GQS
Oct 30, 1987	K864981	TOXOPLASMA GONDII Virion (U.S.), Inc.	GMN

Latest recalls

Date	Firm and product	Code	Linked 510(k)
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