Cleared Traditional

K912136 - CHOLESTECH LIPID MONITORING SYS.
(FDA 510(k) Clearance)

K912136 · Cholestech Corp. · Chemistry device

Jul 1991

Decision

77d

Days

Class 1

Risk

K912136 is an FDA 510(k) clearance for the CHOLESTECH LIPID MONITORING SYS.. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).

Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on July 30, 1991, 77 days after receiving the submission on May 14, 1991.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number	K912136 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 14, 1991
Decision Date	July 30, 1991
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement