510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132828Substantially Equivalent

Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3

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

K132828 is the FDA 510(k) clearance record for ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3, a class II device, cleared for Roche Diagnostics on under FDA product code JKR (Radioimmunoassay, Calcitonin). FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K132828.

Clearance record

Decision date
Received
(86 days to decision)
Product code
JKR Radioimmunoassay, Calcitonin
Regulation
21 CFR 862.1140
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JKR

Trailing 12 months
1 clearance under product code JKR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JKR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260