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
K970477Substantially Equivalent

Hyragel ISO-Ldh Kit/hydragel 15 ISO-Ldh Kit

Sebia, Chelsea MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970477 is the FDA 510(k) clearance record for HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT, a class II device, cleared for Sebia on under FDA product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes). FDA records list 7 510(k) clearances for Sebia, from to . As of , FDA records show no recalls naming K970477.

Clearance record

Decision date
Received
(31 days to decision)
Product code
CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
Regulation
21 CFR 862.1445
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sebia 13805 Waterloo, Chelsea MI
510(k) summary
Statement
Third party review
No

Clearances, product code CFE

Trailing 12 months

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

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