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510(k) K850351

PHADEBACT MONOCLONAL GC TEST by Pharmacia, Inc. — Product Code LIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1985
Date Received
January 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

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Other clearances for product code LIC

  • K921075 — PHADEBACT MONOCLONAL GC TEST, MODIFICATION (May 22, 1992)
  • K911430 — IDEIA(TM) CHLAMYDIA, MODIFICATION (August 7, 1991)
  • K880076 — G-MARK (July 1, 1988)
  • K874078 — MERITEC(TM)-GC (December 9, 1987)
  • K871105 — THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE (May 13, 1987)
  • K851650 — PHADEBACT MONOCLONAL GC OMNI TEST (July 12, 1985)
  • K821362 — IMPROVED GONO GEN (August 4, 1982)
  • K820007 — NEISSERIA GONORRHOEAE TEST (January 29, 1982)