Cleared Traditional

CAL-CHEX CD PLUS

K020469 · Streck Laboratories, Inc. · Hematology

Apr 2002

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K020469 is an FDA 510(k) clearance for the CAL-CHEX CD PLUS, a Calibrator For Cell Indices (Class II — Special Controls, product code KRX), submitted by Streck Laboratories, Inc. (La Vista, US). The FDA issued a Cleared decision on April 4, 2002, 51 days after receiving the submission on February 12, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8150.

Submission Details

510(k) Number	K020469 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2002
Decision Date	April 04, 2002
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF