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510(k) K861835

MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST by Syva Co. — Product Code GTH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1986
Date Received
May 13, 1986
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

  • K900546 — BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT (June 15, 1990)
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