Cleared Traditional

CHART-TYPE MICRO HEMATOCRIT TUBE READER

K870511 · Norfolk Scientific, Inc. · Hematology
Mar 1987
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K870511 is an FDA 510(k) clearance for the CHART-TYPE 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 March 16, 1987, 39 days after receiving the submission on February 5, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number K870511 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1987
Decision Date March 16, 1987
Days to Decision 39 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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