Cleared Traditional

CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE

K880049 · Sclavo, Inc. · Chemistry
Jan 1989
Decision
387d
Days
Class 1
Risk

About This 510(k) Submission

K880049 is an FDA 510(k) clearance for the CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE, a Colorimetry, Cholinesterase (Class I — General Controls, product code DIH), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on January 27, 1989, 387 days after receiving the submission on January 6, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number K880049 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1988
Decision Date January 27, 1989
Days to Decision 387 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DIH — Colorimetry, Cholinesterase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3240

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