510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K063276Substantially Equivalent

Clinitek Advantus, Model 1420

Medrad, Inc., Norowood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063276 is the FDA 510(k) clearance record for CLINITEK ADVANTUS, MODEL 1420, a class II device, cleared for Bayer Healthcare, LLC on under FDA product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)). FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show no recalls naming K063276.

Clearance record

Decision date
Received
(59 days to decision)
Product code
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation
21 CFR 862.1340
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bayer Healthcare, LLC 2 Edgewater Dr., Norowood MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIL

Trailing 12 months

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

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