Cleared Traditional

IL TEST ACID PHOSPHATASE

K943366 · Instrumentation Laboratory CO · Chemistry
Jan 1996
Decision
565d
Days
Class 2
Risk

About This 510(k) Submission

K943366 is an FDA 510(k) clearance for the IL TEST ACID PHOSPHATASE, a Acid Phosphatase, Naphthyl Phosphate (Class II — Special Controls, product code CKB), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 29, 1996, 565 days after receiving the submission on July 13, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K943366 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1994
Decision Date January 29, 1996
Days to Decision 565 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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