Cleared Traditional

SICKLE CELL REAGENT SET

K860812 · Michclone Associates, Inc. · Hematology
Apr 1986
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K860812 is an FDA 510(k) clearance for the SICKLE CELL REAGENT SET, a Test, Sickle Cell (Class II — Special Controls, product code GHM), submitted by Michclone Associates, Inc. (Detroit, US). The FDA issued a Cleared decision on April 11, 1986, 38 days after receiving the submission on March 4, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7825.

Submission Details

510(k) Number K860812 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1986
Decision Date April 11, 1986
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GHM — Test, Sickle Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7825