Cleared Traditional

UA-CELLULAR FOR IQ

K090201 · Streck · Hematology
Mar 2009
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K090201 is an FDA 510(k) clearance for the UA-CELLULAR FOR IQ, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Streck (La Vista, US). The FDA issued a Cleared decision on March 27, 2009, 59 days after receiving the submission on January 27, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K090201 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2009
Decision Date March 27, 2009
Days to Decision 59 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625