Cleared Traditional

PARA 5X

K011410 · Streck Laboratories, Inc. · Hematology

Jun 2001

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K011410 is an FDA 510(k) clearance for the 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 26, 2001, 49 days after receiving the submission on May 8, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K011410 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2001
Decision Date	June 26, 2001
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF