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510(k) K872733

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

K872733 is an FDA 510(k) premarket notification submitted by Whittaker Bioproducts, Inc. for the device "FIAX TEST KIT FOR MUMPS-G ANTIBODIES". The FDA issued a decision of Substantially Equivalent on October 6, 1987. The device falls under product code GRB (Antiserum, Cf, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Whittaker Bioproducts, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Whittaker Bioproducts, Inc.

  • K911356 — LEGIONELLA STAT IGG/IGM TEST KIT (July 30, 1992)
  • K913212 — 3M IGE SINGLE POINT FAST TEST (November 22, 1991)
  • K904652 — LYME STAT M TEST KIT (October 21, 1991)
  • K904893 — FIAX LYME M TEST KIT (October 16, 1991)
  • K911473 — EBNA STAT TEST KIT (September 25, 1991)
  • K905468 — PYLORI-G FIAX TEST KIT (May 7, 1991)
  • K904738 — PYLORI STAT TEST KIT (May 7, 1991)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)
  • 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)

FDA data resources