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510(k) K872733

FIAX TEST KIT FOR MUMPS-G ANTIBODIES by Whittaker Bioproducts, Inc. — Product Code GRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1987
Date Received
July 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Mumps Virus
Device Class
Class I
Regulation Number
866.3380
Review Panel
MI
Submission Type

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  • K894932 — FIAX EB VCA-M TEST KIT (October 16, 1989)

Other clearances for product code GRB

  • K872699 — MUMPS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)