VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET

Multi-analyte Controls, All Kinds (assayed)

MAINE STANDARDS CO.

The following data is part of a premarket notification filed by Maine Standards Co. with the FDA for Validate Cardiac Marker (cm1) Calibration Verification Test Set.

Pre-market Notification Details

• Device ID: K053247
• 510k Number: K053247
• Device Name: VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365
• Contact: Christine Beach
• Correspondent: Christine Beach; MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-11-21
• Decision Date: 2006-01-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859110005593	K053247	000
00859110005616	K053247	000
00859110005609	K053247	000