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510(k) K791991

STREP-SPEC by Micro-Media Systems, Inc. — Product Code JSS

K791991 is an FDA 510(k) premarket notification submitted by Micro-Media Systems, Inc. for the device "STREP-SPEC". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), 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
November 13, 1979
Date Received
October 3, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Enterobacteriaceae
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)
  • K823738 — GRAM NEGATIVE BACTERIAL IDENTIF- PANELS (January 7, 1983)
  • K801547 — TEST PANEL FOR PRESUMP. ID/BACT. ORG (September 9, 1980)
  • K770745 — PANEL, GNF, MICRO-ID (June 23, 1977)
  • K770746 — PANEL, IDENTIFICATION, STREP, MICRO-ID (June 23, 1977)

Other clearances for product code JSS

  • K150031 — hemoFISH Masterpanel (October 1, 2015)
  • K123418 — GRAM-NEGATIVE QUICKFISH BC (July 21, 2013)
  • K101558 — GNR TRAFFIC LIGHT PNA FISH (December 16, 2010)
  • K092236 — E.COLI/P. AERUGINOSA PNA FISH (December 16, 2009)
  • K092393 — EK/P. AERUGINOSA PNA FISH (September 1, 2009)
  • K082068 — E. COLI PNA FISH (June 25, 2009)
  • K081433 — EK/P. AERUGINOSA PNA FISH (March 26, 2009)
  • K081309 — E.COLI/P. AERUGINOSA PNA FISH (December 19, 2008)
  • K926002 — ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (September 23, 1993)
  • K926018 — CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM (March 11, 1993)

FDA data resources