510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112430Substantially Equivalent

I-Stat Lactate Test/i-Sat Cg4+cartridge

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

K112430 is the FDA 510(k) clearance record for I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE, a class I device, cleared for Abbott Pont of Care, Inc. on under FDA product code KHP (Acid, Lactic, Enzymatic Method). FDA records list one 510(k) clearance for Abbott Pont of Care, Inc. As of , FDA records show no recalls naming K112430.

Clearance record

Decision date
Received
(118 days to decision)
Product code
KHP Acid, Lactic, Enzymatic Method
Regulation
21 CFR 862.1450
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Abbott Pont of Care, Inc. 400 College Rd. E., Princton NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHP

Trailing 12 months

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

FDA records show no clearances under product code KHP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHP, 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