Cleared Traditional

IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM

K894645 · Dynatech Laboratories, Inc. · Chemistry
Oct 1989
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K894645 is an FDA 510(k) clearance for the IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM, a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on October 17, 1989, 85 days after receiving the submission on July 24, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K894645 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1989
Decision Date October 17, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JTC — Device, Microtiter Diluting/dispensing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2500

Similar Devices — JTC Device, Microtiter Diluting/dispensing

All 65
FILTERMATE UNIVERSAL HARVESTER
K924907 · Packard Instrument Co., Inc. · Dec 1992
MICROMATE 196 MODEL A961960
K901808 · Packard Instrument Co., Inc. · Jun 1990
MULTI-PROBE HEAD PLUS
K892369 · Hamilton Co. · Jun 1989
GENETIC SYSTEMS PIPETTOR/DILUTOR
K891765 · Genetic Systems Corp. · May 1989
GENETIC SYSTEMS MICROPLATE STRIP WASHER
K891766 · Genetic Systems Corp. · May 1989
GENETIC SYSTEMS MICROPLATE WASHER
K891768 · Genetic Systems Corp. · May 1989