Cleared Traditional

IMMULON SUBSTRATE REMOVAWELL STRIPS

K832117 · Dynatech Corp. · Chemistry
Aug 1983
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K832117 is an FDA 510(k) clearance for the IMMULON SUBSTRATE REMOVAWELL STRIPS, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Dynatech Corp. (Walker, US). The FDA issued a Cleared decision on August 8, 1983, 39 days after receiving the submission on June 30, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K832117 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1983
Decision Date August 08, 1983
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LIB — Device, General Purpose, Microbiology, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

Similar Devices — LIB Device, General Purpose, Microbiology, Diagnostic

All 42
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
K023677 · Osmetech · Jan 2003
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
K920416 · Behring Diagnostics, Inc. · Apr 1992
GULL ELISAWARE
K912558 · Gull Laboratories, Inc. · Sep 1991
CORNING EASY WASH ELISA PLATES
K872273 · Corning Medical & Scientific · Jul 1987
CELL LIFTER
K871559 · Corning Costar Corp. · May 1987
NORMAL SALINE STERILE
K864249 · Mds Laboratories, Inc. · Mar 1987