Cleared Traditional

APPRAISE-CARDIO SAMPLE COLLECTION KIT

K993787 · Osborn Group, Inc. · Chemistry
Apr 2000
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K993787 is an FDA 510(k) clearance for the APPRAISE-CARDIO SAMPLE COLLECTION KIT, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Osborn Group, Inc. (Olathe, US). The FDA issued a Cleared decision on April 14, 2000, 157 days after receiving the submission on November 9, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K993787 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1999
Decision Date April 14, 2000
Days to Decision 157 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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