510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923499Substantially Equivalent

Spectrolyse Heparin Kit

Biopool AB, Ontario, L7l 6b8, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923499 is the FDA 510(k) clearance record for SPECTROLYSE HEPARIN KIT, a class II device, cleared for Biopool AB on under FDA product code KFF (Assay, Heparin). FDA records list 13 510(k) clearances for Biopool AB, from to . As of , FDA records show no recalls naming K923499.

Clearance record

Decision date
Received
(561 days to decision)
Product code
KFF Assay, Heparin
Regulation
21 CFR 864.7525
Device class
Class II
Review panel
Hematology
Applicant
Biopool AB 1016 Sutton Dr., Ontario, L7l 6b8, CA
510(k) summary
Statement
Third party review
No

Clearances, product code KFF

Trailing 12 months
1 clearance under product code KFF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KFF, 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 20261
October 20260