510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894359Substantially Equivalent

Clotrac Citrated Whole Blood Coagulation Controls

Hemotec, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894359 is the FDA 510(k) clearance record for CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS, a class II device, cleared for Hemotec, Inc. on under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies). FDA records list 15 510(k) clearances for Hemotec, Inc., from to . As of , FDA records show no recalls naming K894359.

Clearance record

Decision date
Received
(53 days to decision)
Product code
JPA System, Multipurpose For In Vitro Coagulation Studies
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Hemotec, Inc. 7103 S. Revere Pkwy., Englewood CO
Third party review
No

Clearances, product code JPA

Trailing 12 months
1 clearance under product code JPA in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JPA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260