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510(k) K823738

GRAM NEGATIVE BACTERIAL IDENTIF- PANELS by Micro-Media Systems, Inc. — Product Code JTO

K823738 is an FDA 510(k) premarket notification submitted by Micro-Media Systems, Inc. for the device "GRAM NEGATIVE BACTERIAL IDENTIF- PANELS". The FDA issued a decision of Substantially Equivalent on January 7, 1983. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Micro-Media Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
December 13, 1982
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 Micro-Media Systems, Inc.

  • K953422 — FOX FASTIDIOUS TEST PANELS (October 7, 1995)
  • K945997 — MODIFIED FOX EXTRA GRAM POSITIVE (February 16, 1995)
  • K801547 — TEST PANEL FOR PRESUMP. ID/BACT. ORG (September 9, 1980)
  • K791991 — STREP-SPEC (November 13, 1979)
  • K770746 — PANEL, IDENTIFICATION, STREP, MICRO-ID (June 23, 1977)
  • K770745 — PANEL, GNF, MICRO-ID (June 23, 1977)

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