Cleared Traditional

CD-CHEX CD4 LOW

K931825 · Streck Laboratories, Inc. · Hematology

Jun 1994

Decision

426d

Days

Class 2

Risk

About This 510(k) Submission

K931825 is an FDA 510(k) clearance for the CD-CHEX CD4 LOW, a Control, White-cell (Class II — Special Controls, product code GGL), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on June 6, 1994, 426 days after receiving the submission on April 6, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K931825 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 1993
Decision Date	June 06, 1994
Days to Decision	426 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF