AUTODELFIA NEONATAL HTSH L KIT (B077-112)— 510(k) K973276

Substantially Equivalent

Eg &G Wallac

FDA 510(k) clearance K973276 for AUTODELFIA NEONATAL HTSH L KIT (B077-112), Substantially Equivalent on 1997-11-20. Applicant: Eg &G Wallac.

Clearance details

Applicant: Eg &G Wallac
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1997-09-02
Decision date: 1997-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, 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.