510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061069Substantially Equivalent

Spife Ife-15 Pentavalent, Model 3456, Spife Ife-9 Pentavalent Kit, Model 3457, Spift Ife-6 Pentavalent Kit, Model 3458

Helena Laboratories, Corp., Beaumont TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061069 is the FDA 510(k) clearance record for SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458, a class II device, cleared for Helena Laboratories on under FDA product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K061069.

Clearance record

Decision date
Received
(80 days to decision)
Product code
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Helena Laboratories 1530 Lindbergh Dr., Beaumont TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CFF

Trailing 12 months

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

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