Crit-Line Anemia Management Software

FDA 510(k) K093834 · Hema Metrics, LLC

Substantially Equivalent

510(k) numberK093834

Submission

Device name
Crit-Line Anemia Management Software
Applicant
Hema Metrics, LLC
Ogden, UT, US
Received
December 14, 2009
Decision date
September 29, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MSQ – Test, Urea (Breath Or Blood)
Device class
Class I (low risk)
Regulation
21 CFR 866.3110
Specialty
Microbiology

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Questions and answers

When was Crit-Line Anemia Management Software cleared by the FDA?

Crit-Line Anemia Management Software (K093834) received a 510(k) decision of Substantially Equivalent on September 29, 2010, 289 days after the submission was received.

What is the product code of K093834?

The FDA product code is MSQ – Test, Urea (Breath Or Blood), a Class I (low risk) device regulated under 21 CFR 866.3110.