Cleared Traditional

MICROELISA MINIREADER II

K830200 · Dynatech Corp. · Chemistry
Feb 1983
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K830200 is an FDA 510(k) clearance for the MICROELISA MINIREADER II, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on February 16, 1983, 27 days after receiving the submission on January 20, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K830200 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 1983
Decision Date February 16, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LBI — Unit, Neonatal Phototherapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5700

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