510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022455Substantially Equivalent

Spife Ld-12 Kit, Model 3338

Helena Laboratories, Corp., Beaumont TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K022455 is the FDA 510(k) clearance record for SPIFE LD-12 KIT, MODEL 3338, a class II device, cleared for Helena Laboratories on under FDA product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K022455.

Clearance record

Decision date
Received
(67 days to decision)
Product code
CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
Regulation
21 CFR 862.1445
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Helena Laboratories 1530 Lindbergh Dr., Beaumont TX
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