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510(k) K781802

WASHER SYSTEM, MICROELISA by Metrix Teknika, Inc. — Product Code JTC

K781802 is an FDA 510(k) premarket notification submitted by Metrix Teknika, Inc. for the device "WASHER SYSTEM, MICROELISA". The FDA issued a decision of Substantially Equivalent on December 20, 1978. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Metrix Teknika, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1978
Date Received
October 23, 1978
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 Metrix Teknika, Inc.

  • K781803 — FILTER, EYRPUR DISPOSABLE LEUKOCITE (January 17, 1979)
  • K781348 — FOCISCAN ECHOVISOR SYSTEM (October 3, 1978)
  • K780035 — MINIVISOR (March 6, 1978)

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)
  • K891766 — GENETIC SYSTEMS MICROPLATE STRIP WASHER (May 1, 1989)
  • K891765 — GENETIC SYSTEMS PIPETTOR/DILUTOR (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