Cleared Traditional

DADE ESR KIT

K823368 · American Dade · Hematology
Dec 1982
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K823368 is an FDA 510(k) clearance for the DADE ESR KIT, a Test, Erythrocyte Sedimentation Rate (Class I — General Controls, product code JPH), submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982, 48 days after receiving the submission on November 10, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6700.

Submission Details

510(k) Number K823368 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 1982
Decision Date December 28, 1982
Days to Decision 48 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