I-STAT LACTATE TEST— 510(k) K982071

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K982071 for I-STAT LACTATE TEST, Substantially Equivalent on 1998-06-29. Applicant: I-Stat Corp.. Device class: 1.

Clearance details

Applicant: I-Stat Corp.
Product code: Code KHP
Device class: Class 1
Regulation: 21 CFR 862.1450
Advisory panel: Clinical Chemistry
Date received: 1998-06-12
Decision date: 1998-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHP

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K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER2012-05-03
K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM2012-01-05
K112430 — I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE2011-12-20
K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS2011-08-17

More clearances from I-Stat Corp.

K012478 — MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER2001-08-20
K011478 — I-STAT SYSTEM2001-07-02
K001387 — I-STAT PORTABLE CLINICAL ANALYZER, MODEL 3002000-10-05
K001154 — I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER2000-04-18
K992571 — I-STAT SYSTEM2000-02-10

Recalls naming K982071

K-number listed on FDA's recall record

Z-2582-2025 — i-STAT CG4+ cartridge (white). List Number: 03P85-25.Class II·Ongoing·Abbott Point Of Care Inc.·20250821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982071.

Data sourced from openFDA. This site is unofficial and independent of the FDA.