510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183680Substantially 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)

K183680 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 JPI (Device, Hematocrit Measuring). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K183680.

Clearance record

Decision date
Received
(427 days to decision)
Product code
JPI Device, Hematocrit Measuring
Regulation
21 CFR 864.6400
Device class
Class II
Review panel
Hematology
Applicant
Abbott Point of Care, Inc. 400 College Rd. E., Princton NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JPI

Trailing 12 months

FDA records hold no clearances under product code JPI in the trailing twelve months.

FDA records show no clearances under product code JPI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JPI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260