510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K003941Substantially Equivalent

Elecsys Hcg Stat Claset II

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

K003941 is the FDA 510(k) clearance record for ELECSYS HCG STAT CLASET II, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code JIS (Calibrator, Primary). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K003941.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JIS Calibrator, Primary
Regulation
21 CFR 862.1150
Device class
Class II
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 JIS

Trailing 12 months

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

FDA records show no clearances under product code JIS in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260