510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K111932Substantially Equivalent

Iglucose System

Positiveid Corporation, Delray Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111932 is the FDA 510(k) clearance record for IGLUCOSE SYSTEM, a class II device, cleared for Positiveid Corporation on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list one 510(k) clearance for Positiveid Corporation. As of , FDA records show no recalls naming K111932.

Clearance record

Decision date
Received
(125 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
Positiveid Corporation 1690 S. Congress Ave., Delray Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBW

Trailing 12 months
4 clearances under product code NBW in the twelve months to October 2026, October 2026 the highest month at 2.
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 20262