510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010039Substantially Equivalent

Quicktek Blood Glucose System, Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, Quicktek Control Solution

Chronimed, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010039 is the FDA 510(k) clearance record for QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION, a class II device, cleared for Chronimed, Inc. on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 5 510(k) clearances for Chronimed, Inc., from to . As of , FDA records show no recalls naming K010039.

Clearance record

Decision date
Received
(217 days to decision)
Product code
NBW System, Test, Blood Glucose, Over The Counter
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Chronimed, Inc. 6214 Bury Dr., Eden Prairie MN
510(k) summary
Summary
Third party review
No

Clearances, product code NBW

Trailing 12 months
2 clearances under product code NBW in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260