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510(k) K883486

GONOSTAT by Technology Management & Marketing, Inc. — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
August 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Neisseria
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

Other clearances by Technology Management & Marketing, Inc.

  • K872325 — GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT (August 12, 1987)
  • K872326 — GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT (August 11, 1987)

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