Cleared Traditional

ULTRA CHEM BUN-UV #65080-65081

K830241 · Emd Chemicals, Inc. · Chemistry
Apr 1983
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K830241 is an FDA 510(k) clearance for the ULTRA CHEM BUN-UV #65080-65081, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983, 70 days after receiving the submission on January 25, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K830241 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1983
Decision Date April 05, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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