Cleared Traditional

TRIGLYCERIDES REAGENT

K954187 · Schiapparelli Biosystems, Inc. · Chemistry
Oct 1995
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K954187 is an FDA 510(k) clearance for the TRIGLYCERIDES REAGENT, a Colorimetric Method, Triglycerides (Class I — General Controls, product code JGY), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on October 23, 1995, 47 days after receiving the submission on September 6, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K954187 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1995
Decision Date October 23, 1995
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGY — Colorimetric Method, Triglycerides
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1705

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