Cleared Traditional

STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER

K902028 · Norfolk Scientific, Inc. · Hematology
Jun 1990
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K902028 is an FDA 510(k) clearance for the STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER, a Device, Hematocrit Measuring (Class II — Special Controls, product code JPI), submitted by Norfolk Scientific, Inc. (Norwood, US). The FDA issued a Cleared decision on June 20, 1990, 47 days after receiving the submission on May 4, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number K902028 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1990
Decision Date June 20, 1990
Days to Decision 47 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPI — Device, Hematocrit Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6400

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