Cleared Traditional

MICROTEK MEDICAL'S BLOOD COLLECTION KIT

K900726 · Microbio-Medics, Inc. · Chemistry
May 1990
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K900726 is an FDA 510(k) clearance for the MICROTEK MEDICAL'S BLOOD COLLECTION KIT, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Microbio-Medics, Inc. (Columbus, US). The FDA issued a Cleared decision on May 4, 1990, 78 days after receiving the submission on February 15, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K900726 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1990
Decision Date May 04, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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