Home / 510(k) Clearances / K861774

510(k) K861774

QUADRA-TITER (TM) I.D. (MODIFICATION) by Microtech Medical Systems, Inc. — Product Code JSS

K861774 is an FDA 510(k) premarket notification submitted by Microtech Medical Systems, Inc. for the device "QUADRA-TITER (TM) I.D. (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on May 20, 1986. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), a Class I device regulated under 21 CFR 866.2660. Microtech Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1986
Date Received
May 7, 1986
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 Microtech Medical Systems, Inc.

  • K935485 — FAS FASTIDIOUS MIC PANEL (February 16, 1995)
  • K901598 — FASTIDIOUS MIC PANEL (November 8, 1990)
  • K896332 — SUPPLEMENT TO ANAEROBIC MIC PANEL (February 5, 1990)
  • K884831 — ANAEROBIC MIC PANEL (March 27, 1989)
  • K863847 — MIC - CONCEPT(TM) RX-2 (December 18, 1986)
  • K860208 — QUADRA-TITER I.D. (March 3, 1986)
  • K852613 — MIC-CONCEPT SYSTEM (September 20, 1985)
  • K853745 — MIC-CONCEPT VIEWBOX (September 19, 1985)
  • K850725 — QUADRA TITER MICRO PLATES (April 30, 1985)
  • K851020 — MIC-CONCEPT INOCULATOR (March 29, 1985)

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