VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

Plasma, Coagulation Control

MAINE STANDARDS COMPANY LLC

The following data is part of a premarket notification filed by Maine Standards Company Llc with the FDA for Validate® D-dimer Calibration Verification/ Linearity Test Kit.

Pre-market Notification Details

• Device ID: K162705
• 510k Number: K162705
• Device Name: VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
• Classification: Plasma, Coagulation Control
• Applicant: MAINE STANDARDS COMPANY LLC 221 US ROUTE 1 Cumberland Foreside, ME 04110
• Contact: James Champlin
• Correspondent: James Champlin; MAINE STANDARDS COMPANY LLC 221 US ROUTE 1 Cumberland Foreside, ME 04110
• Product Code: GGN
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-28
• Decision Date: 2017-01-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859110005074	K162705	000