510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K893404Substantially Equivalent

Integra(tm) Blood Glucose Monitoring System

Apprise, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893404 is the FDA 510(k) clearance record for INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM, a class II device, cleared for Apprise, Inc. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list one 510(k) clearance for Apprise, Inc. As of , FDA records show no recalls naming K893404.

Clearance record

Decision date
Received
(93 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Apprise, Inc. 5000 Old Ironsides Dr., Santa Clara CA
Third party review
No

Clearances, product code CGA

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