VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004

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 Chem 4 Calibration Verification Test Set, Model 10004.

Pre-market Notification Details

• Device ID: K012120
• 510k Number: K012120
• Device Name: VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365
• Contact: Christine V Beach
• Correspondent: Christine V 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: 2001-07-06
• Decision Date: 2001-08-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859110005500	K012120	000