Cleared Traditional

MICROFLUOR READER

K822772 · Dynatech Corp. · Chemistry
Oct 1982
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K822772 is an FDA 510(k) clearance for the MICROFLUOR READER, a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1982, 43 days after receiving the submission on September 14, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.

Submission Details

510(k) Number K822772 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1982
Decision Date October 27, 1982
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KHO — Fluorometer, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2560

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