Cleared Traditional

CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772

K991834 · Cholestech Corp. · Chemistry
Sep 1999
Decision
104d
Days
Class 1
Risk

About This 510(k) Submission

K991834 is an FDA 510(k) clearance for the CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772, a Hydrazone Colorimetry, Alt/sgpt (Class I — General Controls, product code CKD), submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on September 9, 1999, 104 days after receiving the submission on May 28, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K991834 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1999
Decision Date September 09, 1999
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CKD — Hydrazone Colorimetry, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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