Cleared Special

MODIFICATION TO PARA 5X

K021922 · Streck Laboratories, Inc. · Hematology

Jun 2002

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K021922 is an FDA 510(k) clearance for the MODIFICATION TO PARA 5X, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Streck Laboratories, Inc. (La Vista, US). The FDA issued a Cleared decision on June 25, 2002, 14 days after receiving the submission on June 11, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K021922 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2002
Decision Date	June 25, 2002
Days to Decision	14 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF