510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854377Substantially Equivalent

Hemotec Cv Whole Blood Coagulation Controls

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

K854377 is the FDA 510(k) clearance record for HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS, a class II device, cleared for Hemotec, Inc. on under FDA product code JOX (Analyzer, Heparin, Automated). FDA records list 15 510(k) clearances for Hemotec, Inc., from to . As of , FDA records show no recalls naming K854377.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JOX Analyzer, Heparin, Automated
Regulation
21 CFR 864.5680
Device class
Class II
Review panel
Hematology
Applicant
Hemotec, Inc. 14 Codding Rd., Attleboro MA
Third party review
No

Clearances, product code JOX

Trailing 12 months

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

FDA records show no clearances under product code JOX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOX, 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