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510(k) K851019

MIC-CONCEPT INOCULUM SEED TRAY by Microtech Medical Systems, Inc. — Product Code JTC

K851019 is an FDA 510(k) premarket notification submitted by Microtech Medical Systems, Inc. for the device "MIC-CONCEPT INOCULUM SEED TRAY". The FDA issued a decision of Substantially Equivalent on March 29, 1985. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Microtech Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1985
Date Received
March 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Microtiter Diluting/Dispensing
Device Class
Class I
Regulation Number
866.2500
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)
  • K861774 — QUADRA-TITER (TM) I.D. (MODIFICATION) (May 20, 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)

Other clearances for product code JTC

  • K924907 — FILTERMATE UNIVERSAL HARVESTER (December 1, 1992)
  • K901808 — MICROMATE 196 MODEL A961960 (June 20, 1990)
  • K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (October 17, 1989)
  • K892369 — MULTI-PROBE HEAD PLUS (June 2, 1989)
  • K891768 — GENETIC SYSTEMS MICROPLATE WASHER (May 1, 1989)
  • K891765 — GENETIC SYSTEMS PIPETTOR/DILUTOR (May 1, 1989)
  • K891766 — GENETIC SYSTEMS MICROPLATE STRIP WASHER (May 1, 1989)
  • K884695 — WASHER 500 MICROELISA SYSTEM (December 13, 1988)
  • K884125 — BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (December 2, 1988)
  • K874598 — DYNATECH MR 250 MANUAL MICROELISA READER (November 20, 1987)

FDA data resources