Cleared Traditional

CD-CHEX PLUS BC

K051633 · Streck · Hematology

Aug 2005

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K051633 is an FDA 510(k) clearance for the CD-CHEX PLUS BC, a Control, White-cell (Class II — Special Controls, product code GGL), submitted by Streck (La Vista, US). The FDA issued a Cleared decision on August 16, 2005, 57 days after receiving the submission on June 20, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K051633 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2005
Decision Date	August 16, 2005
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF