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510(k) K921618

COXSACKIE VIRUS B1-B6 CF ANTIGENS by Virion (U.S.), Inc. — Product Code GNG

K921618 is an FDA 510(k) premarket notification submitted by Virion (U.S.), Inc. for the device "COXSACKIE VIRUS B1-B6 CF ANTIGENS". The FDA issued a decision of Substantially Equivalent on June 29, 1992. The device falls under product code GNG (Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6), a Class I device regulated under 21 CFR 866.3145. Virion (U.S.), Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1992
Date Received
April 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
Device Class
Class I
Regulation Number
866.3145
Review Panel
MI
Submission Type

Other clearances by Virion (U.S.), Inc.

  • K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (June 13, 1994)
  • K905306 — MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN (June 17, 1991)
  • K905385 — P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (March 21, 1991)
  • K864981 — TOXOPLASMA GONDII (October 30, 1987)

Other clearances for product code GNG

  • K850003 — COXSACKIE B SERIES CF ANTIGENS (March 5, 1985)

FDA data resources