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510(k) K820821

MIC-2000 PLUS, 96 CHANNEL DISPENSER by Dynatech Corp. — Product Code JTC

K820821 is an FDA 510(k) premarket notification submitted by Dynatech Corp. for the device "MIC-2000 PLUS, 96 CHANNEL DISPENSER". The FDA issued a decision of Substantially Equivalent on April 14, 1982. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Dynatech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1982
Date Received
March 24, 1982
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 Dynatech Corp.

  • K904567 — DYNATECH MR4000 MICROPLATE READER (January 28, 1991)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854603 — MULTI MASH 2000 (December 6, 1985)
  • K832117 — IMMULON SUBSTRATE REMOVAWELL STRIPS (August 8, 1983)
  • K823787 — HANDI-WASH (March 9, 1983)
  • K823833 — MICRO STIX #011-010-5000 & HOLDER#5100 (March 8, 1983)
  • K830200 — MICROELISA MINIREADER II (February 16, 1983)
  • K823773 — PROVIAL II #006-010-0201 (January 21, 1983)
  • K823557 — REMOVAWELL PLATE LID (December 28, 1982)

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)
  • K891765 — GENETIC SYSTEMS PIPETTOR/DILUTOR (May 1, 1989)
  • K891768 — GENETIC SYSTEMS MICROPLATE WASHER (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