Cleared Traditional

FRUCTOSAMINE, MODEL FR 106-01

K991246 · A.P. Total Care, Inc. · Chemistry
Dec 1999
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K991246 is an FDA 510(k) clearance for the FRUCTOSAMINE, MODEL FR 106-01, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on December 16, 1999, 248 days after receiving the submission on April 12, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K991246 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1999
Decision Date December 16, 1999
Days to Decision 248 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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