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510(k) K885310

MURINE MONOCLONAL ANTI-ADENOVIRUS IGG by Whittaker Bioproducts, Inc. — Product Code GNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1989
Date Received
December 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Adenovirus 1-33
Device Class
Class I
Regulation Number
866.3020
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)
  • K904738 — PYLORI STAT TEST KIT (May 7, 1991)
  • K905468 — PYLORI-G FIAX 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 GNY

  • K922801 — RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY (January 6, 1993)
  • K770811 — ADENOVIRUS GROUP-FA LABELLED PRESERUM (May 20, 1977)
  • K770807 — ADENOVIRUS-GROUP FA LABELLED (8-651 RF) (May 20, 1977)