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510(k) K894645

IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM by Dynatech Laboratories, Inc. — Product Code JTC

K894645 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM". The FDA issued a decision of Substantially Equivalent on October 17, 1989. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1989
Date Received
July 24, 1989
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 Laboratories, Inc.

  • K962265 — MLX MICROTITER PLATE LUMINOMETER (July 25, 1996)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K943701 — MRX MICROPLATE READER (October 20, 1994)
  • K923456 — MICROLITE MICROTITER PLATE LUMINOMETER ML3000 (October 13, 1992)
  • K915896 — MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI (May 4, 1992)
  • K920888 — MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (March 19, 1992)
  • K913590 — MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER (October 25, 1991)
  • K895313 — MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER (October 17, 1989)
  • K894687 — DYNATECH MR 5000, CATALOG #011-976-0600 (August 31, 1989)
  • K890502 — MICROLITE TUBE LUMINOMETER #011-902-0000 (February 27, 1989)

Other clearances for product code JTC

  • K924907 — FILTERMATE UNIVERSAL HARVESTER (December 1, 1992)
  • K901808 — MICROMATE 196 MODEL A961960 (June 20, 1990)
  • 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)
  • K873542 — MICROPLATE AUTO-WASHER (MOTORIZED STAGE) (September 23, 1987)

FDA data resources