AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT— 510(k) K942661

Substantially Equivalent

Sealite Sciences, Inc.

FDA 510(k) clearance K942661 for AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT, Substantially Equivalent on 1995-01-17. Applicant: Sealite Sciences, Inc..

Clearance details

Applicant: Sealite Sciences, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1994-06-06
Decision date: 1995-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bogart, GA, 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.