Cleared Traditional

LIPOCLEAR LIPEMIA CLEARING REAGENT

K884807 · Statspin Technologies · Chemistry
Jan 1989
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K884807 is an FDA 510(k) clearance for the LIPOCLEAR LIPEMIA CLEARING REAGENT, 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 January 27, 1989, 71 days after receiving the submission on November 17, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K884807 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1988
Decision Date January 27, 1989
Days to Decision 71 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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