510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K964963Substantially Equivalent

Lyphochek Coagulation Control

Bio-Rad, Anaheim CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964963 is the FDA 510(k) clearance record for LYPHOCHEK COAGULATION CONTROL, a class II device, cleared for Bio-Rad on under FDA product code GGN (Plasma, Coagulation Control). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K964963.

Clearance record

Decision date
Received
(71 days to decision)
Product code
GGN Plasma, Coagulation Control
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Bio-Rad 3726 E. Miraloma Ave., Anaheim CA
510(k) summary
Summary
Third party review
No

Clearances, product code GGN

Trailing 12 months

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

FDA records show no clearances under product code GGN in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GGN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260