SPOTCHEM II LDH TEST

FDA 510(k) Premarket Notification · Submission K050790 · Applicant: Arkray, Inc.

Public Record 510(k) Submission Decision Date: 2005-06-06 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K050790.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K050790

Applicant / Sponsor

Arkray, Inc.

Device Name

SPOTCHEM II LDH TEST

Product Code

CFH

Decision Date

2005-06-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2005-03-28

Related Establishments / Registrations

TECO DIAGNOSTICS Registration: 1832216 View Registration
BIALEX LAB Registration: 3021841051 View Registration

Public Record Disclaimer

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 Information may be outdated or incomplete.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.