Cleared Traditional

ACP KINETIC TEST (ACID PHOSPHATASE TEST)

K881204 · Sclavo, Inc. · Chemistry
Apr 1988
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K881204 is an FDA 510(k) clearance for the ACP KINETIC TEST (ACID PHOSPHATASE TEST), a Acid Phosphatase, Naphthyl Phosphate (Class II — Special Controls, product code CKB), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on April 28, 1988, 38 days after receiving the submission on March 21, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K881204 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1988
Decision Date April 28, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKB — Acid Phosphatase, Naphthyl Phosphate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1020

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