510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063868Substantially Equivalent

Masstrak Immunosuppressants Kit

Waters Corporation, Beverly MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063868 is the FDA 510(k) clearance record for MASSTRAK IMMUNOSUPPRESSANTS KIT, a class II device, cleared for Waters Corporation on under FDA product code MLM (Enzyme Immunoassay, Tracrolimus). FDA records list 6 510(k) clearances for Waters Corporation, from to . As of , FDA records show no recalls naming K063868.

Clearance record

Decision date
Received
(147 days to decision)
Product code
MLM Enzyme Immunoassay, Tracrolimus
Regulation
21 CFR 862.1678
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Waters Corporation 163 Cabot St., Beverly MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MLM

Trailing 12 months

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

FDA records show no clearances under product code MLM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MLM, 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