Cleared Traditional

K870737 - U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
(FDA 510(k) Clearance)

K870737 · U. S. Diagnostics, Inc. · Chemistry

Apr 1987

Decision

47d

Days

Class 1

Risk

K870737 is an FDA 510(k) clearance for the U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL. This device is classified as a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT).

Submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on April 13, 1987, 47 days after receiving the submission on February 25, 1987.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K870737 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 1987
Decision Date	April 13, 1987
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—