Cleared Traditional

CD8 CYTOSPHERES KIT

K923951 · Coulter Electronics, Inc. · Hematology

Apr 1994

Decision

627d

Days

Class 2

Risk

About This 510(k) Submission

K923951 is an FDA 510(k) clearance for the CD8 CYTOSPHERES KIT, a Dna-probe, B And T Lymphocyte (Class II — Special Controls, product code MAM), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on April 25, 1994, 627 days after receiving the submission on August 6, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K923951 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 1992
Decision Date	April 25, 1994
Days to Decision	627 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF