Home / 510(k) Clearances / K921618

510(k) K921618

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

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)