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
K960491Substantially Equivalent

Micro Haematocrit Centrifuge

Hawksley & Sons, Ltd., Lancing, West Sussex, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960491 is the FDA 510(k) clearance record for MICRO HAEMATOCRIT CENTRIFUGE, a class II device, cleared for Hawksley & Sons , Ltd. on under FDA product code CKG (Radioimmunoassay, Acth). FDA records list one 510(k) clearance for Hawksley & Sons , Ltd. As of , FDA records show no recalls naming K960491.

Clearance record

Decision date
Received
(260 days to decision)
Product code
CKG Radioimmunoassay, Acth
Regulation
21 CFR 862.1025
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hawksley & Sons , Ltd. Marlborough Rd., Lancing, West Sussex, GB
510(k) summary
Statement
Third party review
No

Clearances, product code CKG

Trailing 12 months

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

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