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510(k) K905306

MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN by Virion (U.S.), Inc. — Product Code GRC

K905306 is an FDA 510(k) premarket notification submitted by Virion (U.S.), Inc. for the device "MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN". The FDA issued a decision of Substantially Equivalent on June 17, 1991. The device falls under product code GRC (Antigen, Cf (Including Cf Control), Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Virion (U.S.), Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1991
Date Received
November 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Mumps Virus
Device Class
Class I
Regulation Number
866.3380
Review Panel
MI
Submission Type

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

  • K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (June 13, 1994)
  • K921618 — COXSACKIE VIRUS B1-B6 CF ANTIGENS (June 29, 1992)
  • K905385 — P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (March 21, 1991)
  • K864981 — TOXOPLASMA GONDII (October 30, 1987)

Other clearances for product code GRC

  • K832873 — MUMPS COMPLEMENT FIXATION & HEMAGGLU (December 27, 1983)
  • K802933 — MUMPS S & V ANTIGENS & CONTROLS (December 31, 1980)

FDA data resources