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510(k) K023947

GC OIA by Thermo Biostar, Inc. — Product Code LIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2003
Date Received
November 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

Other clearances by Thermo Biostar, Inc.

  • K032330 — CT OIA (March 2, 2004)
  • K023556 — FLU OIA A/B TEST KIT (March 27, 2003)
  • K023779 — RSV OIA (January 14, 2003)
  • K021172 — RSV OIA (September 13, 2002)

Other clearances for product code LIR

  • K882534 — ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL (July 12, 1988)
  • K881064 — HYGEIA GC TEST (June 2, 1988)