Cleared Traditional

K914040 - PHOSPHOLIPID REAGENT SET
(FDA 510(k) Clearance)

K914040 · Sterling Diagnostics, Inc. · Chemistry

Oct 1991

Decision

50d

Days

Class 1

Risk

K914040 is an FDA 510(k) clearance for the PHOSPHOLIPID REAGENT SET. This device is classified as a Chromatographic, Phospholipids (Class I — General Controls, product code JNT).

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on October 30, 1991, 50 days after receiving the submission on September 10, 1991.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1575.

Submission Details

510(k) Number	K914040 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 1991
Decision Date	October 30, 1991
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement