Cleared Traditional

CD-CHEX CD 34

K993126 · Streck Laboratories, Inc. · Hematology

Nov 1999

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K993126 is an FDA 510(k) clearance for the CD-CHEX CD 34, 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 November 26, 1999, 67 days after receiving the submission on September 20, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K993126 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 1999
Decision Date	November 26, 1999
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF