510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080092Substantially Equivalent

Elecsys Anti-Tshr Immunoassay, Elecsys Precicontrol Thyroab

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080092 is the FDA 510(k) clearance record for ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code JZO (System, Test, Thyroid Autoantibody). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K080092.

Clearance record

Decision date
Received
(196 days to decision)
Product code
JZO System, Test, Thyroid Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd. Bx 50416, Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JZO

Trailing 12 months

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

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