FDA 510(k) Premarket Notification K252431: Elecsys Calcitonin

Submission Details & Decision

Normalized public record details for 510(k) notification K252431.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K252431

Applicant / Sponsor

Roche Diagnostics GmbH

Device Name

Elecsys Calcitonin

Product Code

JKR

Decision Date

2026-04-24

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2025-08-01

Related Establishments / Registrations

American Laboratory Products Company Registration: 1222302 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
Biomerica Registration: 2025099 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
DIASORIN INC. Registration: 2182595 View Registration
DRG International, Inc. Registration: 2245285 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
DRG INSTRUMENTS GMBH Registration: 3002800697 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
AXIS-SHIELD DIAGNOSTICS, LTD. Registration: 8032314 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.