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510(k) K900546

BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT by Baxter Healthcare Corp — Product Code GTH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1990
Date Received
February 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

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Other clearances for product code GTH

  • K861835 — MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST (May 29, 1986)
  • K800328 — NEISSERIA GONORRHOEAE FLUORO-KIT (March 3, 1980)