510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080641Substantially Equivalent

Trueresult Blood Glucose System E4h01-81

Home Diagnostics, Inc., Fort Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K080641 is the FDA 510(k) clearance record for TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81, a class II device, cleared for Home Diagnostics, Inc. on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 22 510(k) clearances for Home Diagnostics, Inc., from to . As of , FDA records show one recall naming K080641.

Clearance record

Decision date
Received
(166 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
Home Diagnostics, Inc. 2400 NW 55th Ct., Fort Lauderdale FL
510(k) summary
Statement
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