510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003174Substantially Equivalent

Elecsys Dhea-S

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003174 is the FDA 510(k) clearance record for ELECSYS DHEA-S, a class I device, cleared for Roche Diagnostics Corp. on under FDA product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K003174.

Clearance record

Decision date
Received
(99 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
Roche Diagnostics Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Summary
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