Cleared Traditional

SENTINEL LIPASE LIQUID MODEL 17.401B

K961179 · Equal Diagnostics, Inc. · Chemistry

Jul 1996

Decision

115d

Days

Class 1

Risk

About This 510(k) Submission

K961179 is an FDA 510(k) clearance for the SENTINEL LIPASE LIQUID MODEL 17.401B, a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I — General Controls, product code CHI), submitted by Equal Diagnostics, Inc. (Exton, US). The FDA issued a Cleared decision on July 19, 1996, 115 days after receiving the submission on March 26, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number	K961179 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 1996
Decision Date	July 19, 1996
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement