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510(k) K874078

MERITEC(TM)-GC by Meridian Diagnostics, Inc. — Product Code LIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1987
Date Received
October 6, 1987
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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  • K820007 — NEISSERIA GONORRHOEAE TEST (January 29, 1982)