VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
K-Number: K170864 · 2017-06-21
Device Summary
Frequently Asked Questions
What is the VALIDATE D-Dimer Calibration Verification / Linearity Test Kit?
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit is a medical device that received FDA 510(k) clearance on 2017-06-21. The listed applicant is Maine Standards Company, LLC. The 510(k) number is K170864.
When did VALIDATE D-Dimer Calibration Verification / Linearity Test Kit receive FDA 510(k) clearance?
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit received FDA 510(k) clearance on 2017-06-21, under 510(k) number K170864.
Who is the listed applicant for VALIDATE D-Dimer Calibration Verification / Linearity Test Kit?
The FDA 510(k) record lists Maine Standards Company, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VALIDATE D-Dimer Calibration Verification / Linearity Test Kit?
The FDA product code for VALIDATE D-Dimer Calibration Verification / Linearity Test Kit is GGN.
Other records listing Maine Standards Company, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GGN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.