Ua-Cellular for Iq

FDA 510(k) K090201 · Streck

Substantially Equivalent

510(k) numberK090201

Submission

Device name
Ua-Cellular for Iq
Applicant
Streck
La Vista, NE, US
Received
January 27, 2009
Decision date
March 27, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JPK – Mixture, Hematology Quality Control
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8625
Specialty
Hematology

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Questions and answers

When was Ua-Cellular for Iq cleared by the FDA?

Ua-Cellular for Iq (K090201) received a 510(k) decision of Substantially Equivalent on March 27, 2009, 59 days after the submission was received.

What is the product code of K090201?

The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.