VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901

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 Thyroid Calibration Verification Test Set, Model 901.

Pre-market Notification Details

• Device ID: K083891
• 510k Number: K083891
• Device Name: VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
• 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: 2008-12-29
• Decision Date: 2009-03-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850011135174	K083891	000
00850011135181	K083891	000