Cleared Traditional

ERYTHROCYTE & STAND SEDIMENT. RATE TUBE

K823761 · Cordis Corp. · Hematology
Jan 1983
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K823761 is an FDA 510(k) clearance for the ERYTHROCYTE & STAND SEDIMENT. RATE TUBE, a Test, Erythrocyte Sedimentation Rate (Class I — General Controls, product code JPH), submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983, 38 days after receiving the submission on December 14, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6700.

Submission Details

510(k) Number K823761 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1982
Decision Date January 21, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPH — Test, Erythrocyte Sedimentation Rate
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.6700

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