Cleared Traditional

HDL-CHOLESTEROL STANDARD, MODIFICATION

K924904 · Verichem Laboratories, Inc. · Chemistry
Jan 1993
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K924904 is an FDA 510(k) clearance for the HDL-CHOLESTEROL STANDARD, MODIFICATION, a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Verichem Laboratories, Inc. (Providence, US). The FDA issued a Cleared decision on January 13, 1993, 106 days after receiving the submission on September 29, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K924904 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1992
Decision Date January 13, 1993
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIS — Calibrator, Primary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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