Cleared Traditional

MICROFLUOR B PLATE & MICRO FLUOR W PLATE

K822960 · Dynatech Corp. · Chemistry
Nov 1982
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K822960 is an FDA 510(k) clearance for the MICROFLUOR B PLATE & MICRO FLUOR W PLATE, 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 November 16, 1982, 42 days after receiving the submission on October 5, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K822960 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1982
Decision Date November 16, 1982
Days to Decision 42 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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