Cleared Traditional

HI CHEM PROTEIN/LIPIDS LINEARITY

K903888 · Hichem Diagnostics · Chemistry
Sep 1990
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K903888 is an FDA 510(k) clearance for the HI CHEM PROTEIN/LIPIDS LINEARITY, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on September 27, 1990, 36 days after receiving the submission on August 22, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K903888 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1990
Decision Date September 27, 1990
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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