CHEMWELL, ALSO KNOWN AS PROJECT 2900— 510(k) K013420

Substantially Equivalent

Awareness Technology, Inc.

FDA 510(k) clearance K013420 for CHEMWELL, ALSO KNOWN AS PROJECT 2900, Substantially Equivalent on 2002-07-19. Applicant: Awareness Technology, Inc..

Clearance details

Applicant: Awareness Technology, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2001-10-15
Decision date: 2002-07-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Palm City, FL, US

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.