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510(k) K901808

MICROMATE 196 MODEL A961960 by Packard Instrument Co., Inc. — Product Code JTC

K901808 is an FDA 510(k) premarket notification submitted by Packard Instrument Co., Inc. for the device "MICROMATE 196 MODEL A961960". The FDA issued a decision of Substantially Equivalent on June 20, 1990. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Packard Instrument Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1990
Date Received
April 20, 1990
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 Packard Instrument Co., Inc.

  • K924907 — FILTERMATE UNIVERSAL HARVESTER (December 1, 1992)
  • K913664 — ROSYS MODELS 100 AND 200 (August 30, 1991)
  • K883749 — PROBE(TM) MODELS 700 AND 1000 (November 10, 1988)

Other clearances for product code JTC

  • K924907 — FILTERMATE UNIVERSAL HARVESTER (December 1, 1992)
  • 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)
  • K891766 — GENETIC SYSTEMS MICROPLATE STRIP WASHER (May 1, 1989)
  • K891768 — GENETIC SYSTEMS MICROPLATE 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