510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935469Substantially Equivalent

Synelisa Dhea-Sulfate

Elias U.S.A., Inc., Osceola WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935469 is the FDA 510(k) clearance record for SYNELISA DHEA-SULFATE, a class I device, cleared for Elias U.S.A., Inc. on under FDA product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)). FDA records list 54 510(k) clearances for Elias U.S.A., Inc., from to . As of , FDA records show no recalls naming K935469.

Clearance record

Decision date
Received
(139 days to decision)
Product code
JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Regulation
21 CFR 862.1245
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Elias U.S.A., Inc. 373 280th St., Osceola WI
510(k) summary
Statement
Third party review
No

Clearances, product code JKC

Trailing 12 months

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

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