510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261039Substantially Equivalent

i-STAT Crea cartridge with the i-STAT 1 System

Abbott Medical, Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261039 is the FDA 510(k) clearance record for i-STAT Crea cartridge with the i-STAT 1 System, a class II device, cleared for Abbott Point of Care, Inc. on under FDA product code CGL (Electrode, Ion Based, Enzymatic, Creatinine). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K261039.

Clearance record

Decision date
Received
(88 days to decision)
Product code
CGL Electrode, Ion Based, Enzymatic, Creatinine
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Point of Care, Inc. 400 College Rd. E., Princeton NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CGL

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