510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051409Substantially Equivalent

Slivasure

Scandinavian Formulas, Inc., Sellersville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K051409 is the FDA 510(k) clearance record for SLIVASURE, a class I device, cleared for Scandinavian Formulas, Inc. on under FDA product code LED (Stains, Chemical Solution). FDA records list one 510(k) clearance for Scandinavian Formulas, Inc. As of , FDA records show no recalls naming K051409.

Clearance record

Decision date
Received
(69 days to decision)
Product code
LED Stains, Chemical Solution
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Scandinavian Formulas, Inc. 140 E. Church St., Sellersville PA
510(k) summary
Statement
Third party review
No

Clearances, product code LED

Trailing 12 months

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

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