Cleared Traditional

K873726 - ACID PHOSPHATASE TEST
(FDA 510(k) Clearance)

K873726 · King Diagnostics, Inc. · Chemistry

Jan 1988

Decision

134d

Days

Class 2

Risk

K873726 is an FDA 510(k) clearance for the ACID PHOSPHATASE TEST. This device is classified as a Acid Phosphatase, Thymolphthale Inmonophosphate (Class II — Special Controls, product code CKE).

Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 27, 1988, 134 days after receiving the submission on September 15, 1987.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number	K873726 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 1987
Decision Date	January 27, 1988
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—