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510(k) K864244

GARNERELLA VAGINALIS IDENTIFICATION KIT by Mds Laboratories, Inc. — Product Code JTO

K864244 is an FDA 510(k) premarket notification submitted by Mds Laboratories, Inc. for the device "GARNERELLA VAGINALIS IDENTIFICATION KIT". The FDA issued a decision of Substantially Equivalent on March 31, 1987. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Mds Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1987
Date Received
October 28, 1986
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 by Mds Laboratories, Inc.

  • K864255 — TRYPTICASE SOY BROTH (March 31, 1987)
  • K864245 — MUELLER HINTON AGAR SMALL (March 31, 1987)
  • K864256 — TRYPTONE WATER (1%) (March 31, 1987)
  • K864243 — MACCONKEY AGAR (March 31, 1987)
  • K864239 — CLED AGAR WITH ANDRADES INDICATOR (March 31, 1987)
  • K864254 — THIOGLYCOLLATE BROTH (March 31, 1987)
  • K864252 — THAYER-MARTIN JEMBEC (March 31, 1987)
  • K864238 — CHOCOLATE AGAR (March 31, 1987)
  • K864249 — NORMAL SALINE STERILE (March 31, 1987)
  • K864242 — HEKTOEN ENTERIC AGAR (March 31, 1987)

Other clearances for product code JTO

  • K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (September 1, 2005)
  • 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)

FDA data resources