Cleared Traditional

STATSPIN STATSAMPLER

K896206 · Statspin Technologies · Chemistry
Nov 1989
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K896206 is an FDA 510(k) clearance for the STATSPIN STATSAMPLER, 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 November 22, 1989, 27 days after receiving the submission on October 26, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K896206 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1989
Decision Date November 22, 1989
Days to Decision 27 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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