I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK— 510(k) K912387

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K912387 for I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK, Substantially Equivalent on 1991-07-01. Applicant: I-Stat Corp..

Clearance details

Applicant: I-Stat Corp.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1991-05-01
Decision date: 1991-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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