Cleared Traditional

CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE

K914167 · Eastman Kodak Company · Chemistry
Mar 1992
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K914167 is an FDA 510(k) clearance for the CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE, a Acid Phosphatase, Thymolphthale Inmonophosphate (Class II — Special Controls, product code CKE), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 17, 1992, 182 days after receiving the submission on September 17, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K914167 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 1991
Decision Date March 17, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CKE — Acid Phosphatase, Thymolphthale Inmonophosphate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1020

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