Cleared Traditional

SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM

K012221 · Biosafe Laboratories, Inc. · Chemistry
Apr 2002
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K012221 is an FDA 510(k) clearance for the SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Biosafe Laboratories, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 3, 2002, 261 days after receiving the submission on July 16, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K012221 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2001
Decision Date April 03, 2002
Days to Decision 261 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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