I-STAT SYSTEM— 510(k) K992571

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K992571 for I-STAT SYSTEM, Substantially Equivalent on 2000-02-10. Applicant: I-Stat Corp.. Device class: 2.

Clearance details

Applicant: I-Stat Corp.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1999-08-02
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Windsor, NJ, US

Download summary PDF View on FDA.gov ↗

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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
K982071 — I-STAT LACTATE TEST1998-06-29

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