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510(k) K894235

EB VCA STAT M TEST KIT by Whittaker Bioproducts, Inc. — Product Code LSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1989
Date Received
June 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epstein-Barr Virus, Other
Device Class
Class I
Regulation Number
866.3235
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)

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