510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K100398Substantially Equivalent

Smartlink Gold Blood Glucose Monitoring System

Standard Diagnostics, Inc., Great Neck NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100398 is the FDA 510(k) clearance record for SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM, a class II device, cleared for Standard Diagnostics, Inc. on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 3 510(k) clearances for Standard Diagnostics, Inc., from to . As of , FDA records show no recalls naming K100398.

Clearance record

Decision date
Received
(113 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
Standard Diagnostics, Inc. 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBW

Trailing 12 months
3 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 20261