510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K043007Substantially Equivalent

Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105

Hyphen Biomed Sasu, Mason OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043007 is the FDA 510(k) clearance record for BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105, a class II device, cleared for Hyphen Biomed on under FDA product code JBQ (Antithrombin Iii Quantitation). FDA records list 6 510(k) clearances for HYPHEN BIOMED SASU, from to . As of , FDA records show no recalls naming K043007.

Clearance record

Decision date
Received
(371 days to decision)
Product code
JBQ Antithrombin Iii Quantitation
Regulation
21 CFR 864.7060
Device class
Class II
Review panel
Hematology
Applicant
Hyphen Biomed 6560 Gove Ct., Mason OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JBQ

Trailing 12 months

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

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