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510(k) K050352

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

K050352 is an FDA 510(k) premarket notification submitted by Ameritek Research, LLC for the device "IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT". The FDA issued a decision of Substantially Equivalent on September 1, 2005. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660.

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

Other clearances for product code JTO

  • K970832 — PYR SWAB (April 24, 1997)
  • K970834 — GRAM SWAB (April 17, 1997)
  • K970833 — INDOLE SWAB (April 2, 1997)
  • K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (February 6, 1997)
  • 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)

FDA data resources