Cleared Traditional

K873496 - ATYPICAL CHOLINESTERASE
(FDA 510(k) Clearance)

K873496 · Sclavo, Inc. · Chemistry

Jan 1989

Decision

528d

Days

Class 1

Risk

K873496 is an FDA 510(k) clearance for the ATYPICAL CHOLINESTERASE, 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, 528 days after receiving the submission on August 18, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number	K873496 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 1987
Decision Date	January 27, 1989
Days to Decision	528 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—