Cleared Traditional

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS

K991733 · Schiapparelli Biosystems, Inc. · Chemistry
Jul 1999
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K991733 is an FDA 510(k) clearance for the ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on July 13, 1999, 53 days after receiving the submission on May 21, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K991733 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1999
Decision Date July 13, 1999
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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