Cleared Traditional

STATSPIN MINI-PLASMA

K893613 · Statspin Technologies · Chemistry
Aug 1989
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K893613 is an FDA 510(k) clearance for the STATSPIN MINI-PLASMA, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Statspin Technologies (Norwood, US). The FDA issued a Cleared decision on August 28, 1989, 110 days after receiving the submission on May 10, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K893613 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1989
Decision Date August 28, 1989
Days to Decision 110 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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