510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964609Substantially Equivalent

Actalyke Activated Clotting Time Test System/clotting Time Tubes/whole Blood Qc Kit/actalyke Electronic Clotting Tube

Array Medical, Inc., Bridgewater NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964609 is the FDA 510(k) clearance record for ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE, a class II device, cleared for Array Medical, Inc. on under FDA product code JBP (Activated Whole Blood Clotting Time). FDA records list 3 510(k) clearances for Array Medical, Inc., from to . As of , FDA records show no recalls naming K964609.

Clearance record

Decision date
Received
(108 days to decision)
Product code
JBP Activated Whole Blood Clotting Time
Regulation
21 CFR 864.7140
Device class
Class II
Review panel
Hematology
Applicant
Array Medical, Inc. 245 Rt. 22 W., Bridgewater NJ
510(k) summary
Summary
Third party review
No

Clearances, product code JBP

Trailing 12 months

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

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