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510(k) K864244

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

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.

  • K864251 — SELENITE F. BROTH (March 31, 1987)
  • K864240 — COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD (March 31, 1987)
  • K864237 — CARY BLAIR TRANSPORT MEDIUM (March 31, 1987)
  • K864253 — THAYER MARTIN AGAR (March 31, 1987)
  • K864248 — MUELLER HINTON AGAR - SUPPLEMENTED (March 31, 1987)
  • K864246 — MUELLER HINTON AGAR LARGE (March 31, 1987)
  • K864256 — TRYPTONE WATER (1%) (March 31, 1987)
  • K864241 — DNASE AGAR (March 31, 1987)
  • K864245 — MUELLER HINTON AGAR SMALL (March 31, 1987)
  • K864247 — MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (March 31, 1987)

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  • 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)