Cleared Traditional

MICRO STIX #011-010-5000 & HOLDER#5100

K823833 · Dynatech Corp. · Chemistry
Mar 1983
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K823833 is an FDA 510(k) clearance for the MICRO STIX #011-010-5000 & HOLDER#5100, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1983, 77 days after receiving the submission on December 21, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K823833 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1982
Decision Date March 08, 1983
Days to Decision 77 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

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