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510(k) K050352

IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT by Ameritek Research, LLC — Product Code JTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2005
Date Received
February 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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  • K962966 — IDS RAPID CB PLUS SYSTEM (October 8, 1996)
  • K961191 — COLISCREEN (June 17, 1996)
  • K960996 — M. CAT BUTYRATE DISK (April 18, 1996)
  • K955826 — GIBSON ID-M. CAT. (February 29, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)
  • K954812 — LYFO(TM) DIFFERIENTAL DISK-PYR (December 20, 1995)