VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

Single (specified) Analyte Controls (assayed And Unassayed)

MAINE STANDARDS CO.

The following data is part of a premarket notification filed by Maine Standards Co. with the FDA for Validate Psa Calibration Verification/ Linearity Test Kit Model 406.

Pre-market Notification Details

• Device ID: K123127
• 510k Number: K123127
• Device Name: VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
• Classification: Single (specified) Analyte Controls (assayed And Unassayed)
• Applicant: MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365
• Contact: James W Champlin
• Correspondent: James W Champlin; MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham, ME 04062 -5365
• Product Code: JJX
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-10-04
• Decision Date: 2013-06-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859110005715	K123127	000
00859110005708	K123127	000