Cleared Traditional

STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE

K890669 · Norfolk Scientific, Inc. · Chemistry
Mar 1989
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K890669 is an FDA 510(k) clearance for the STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Norfolk Scientific, Inc. (Norwood, US). The FDA issued a Cleared decision on March 8, 1989, 27 days after receiving the submission on February 9, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K890669 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1989
Decision Date March 08, 1989
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LBR — Ldl & Vldl Precipitation, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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