Cleared Traditional

SICKLE-HEME A/S HETEROZYGOUS CONTROL

K842955 · Michclone Associates, Inc. · Hematology

Aug 1984

Decision

13d

Days

Class 2

Risk

About This 510(k) Submission

K842955 is an FDA 510(k) clearance for the SICKLE-HEME A/S HETEROZYGOUS CONTROL, a Test, Sickle Cell (Class II — Special Controls, product code GHM), submitted by Michclone Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 9, 1984, 13 days after receiving the submission on July 27, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7825.

Submission Details

510(k) Number	K842955 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 1984
Decision Date	August 09, 1984
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—