510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163498Substantially Equivalent

VALIDATE Heparin Calibration Verification/Linearity Test Kit

Maine Standards Co., Cumberland Foreside ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163498 is the FDA 510(k) clearance record for VALIDATE Heparin Calibration Verification/Linearity Test Kit, a class II device, cleared for Maine Standards Company, LLC on under FDA product code GGN (Plasma, Coagulation Control). FDA records list 30 510(k) clearances for Maine Standards Company, LLC, from to . As of , FDA records show no recalls naming K163498.

Clearance record

Decision date
Received
(93 days to decision)
Product code
GGN Plasma, Coagulation Control
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Maine Standards Company, LLC 221 Us Rte. 1, Cumberland Foreside ME
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGN

Trailing 12 months

FDA records hold no clearances under product code GGN in the trailing twelve months.

FDA records show no clearances under product code GGN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GGN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260