VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402

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 Cm2 Calibration Verification / Linearity Test Set, Model 402.

Pre-market Notification Details

• Device ID: K090475
• 510k Number: K090475
• Device Name: VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365
• Contact: Holly Cressman
• Correspondent: Holly Cressman; 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: 2009-02-24
• Decision Date: 2009-04-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859110005630	K090475	000
00859110005685	K090475	000
00859110005654	K090475	000
00859110005647	K090475	000
00859110005623	K090475	000