510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210958Substantially Equivalent

i-STAT CHEM8+ cartridge with the i-STAT 1 System

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

K210958 is the FDA 510(k) clearance record for i-STAT CHEM8+ cartridge with the i-STAT 1 System, a class II device, cleared for Abbott Point of Care, Inc. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K210958.

Clearance record

Decision date
Received
(135 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Point of Care, Inc. 400 College Rd. E., Princton NJ
510(k) summary
Summary PDF
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