510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093834Substantially Equivalent

Crit-Line Anemia Management Software

Hema Metrics, LLC, Ogden UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093834 is the FDA 510(k) clearance record for CRIT-LINE ANEMIA MANAGEMENT SOFTWARE, a class I device, cleared for Hema Metrics, LLC on under FDA product code MSQ (Test, Urea (Breath Or Blood)). FDA records list one 510(k) clearance for Hema Metrics, LLC. As of , FDA records show no recalls naming K093834.

Clearance record

Decision date
Received
(289 days to decision)
Product code
MSQ Test, Urea (Breath Or Blood)
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Hema Metrics, LLC 136 W. 2nd St., Ogden UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSQ

Trailing 12 months

FDA records hold no clearances under product code MSQ in the trailing twelve months.

FDA records show no clearances under product code MSQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260