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510(k) K832873

MUMPS COMPLEMENT FIXATION & HEMAGGLU by Hazleton Dutchland, Inc. — Product Code GRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
August 25, 1983
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 for product code GRC

  • K905306 — MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN (June 17, 1991)
  • K802933 — MUMPS S & V ANTIGENS & CONTROLS (December 31, 1980)