VALIDATE D-Dimer Calibration Verification/Linearity Test Kit— 510(k) K152961

Name: FDA 510(k) clearance K152961
Creator: U.S. Food and Drug Administration
Published: 2016-06-03

Substantially Equivalent

Maine Standards Company, LLC

FDA 510(k) clearance K152961 for VALIDATE D-Dimer Calibration Verification/Linearity Test Kit, Substantially Equivalent on 2016-06-03. Applicant: Maine Standards Company, LLC. Device class: 2.

Clearance details

Applicant: Maine Standards Company, LLC
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2015-10-07
Decision date: 2016-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumberland Foreside, ME, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGN

view all

K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit2017-06-21
K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit2017-03-16
K161316 — George King Coumadin Plasma2017-02-23
K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit2017-01-05
K150144 — VisuCon-F Low Fibrinogen Control Plasma2016-03-06

More clearances from Maine Standards Company, LLC

view all

K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit2015-04-30
K133550 — VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT2014-02-05
K110880 — VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT2011-07-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.