510(k) K955085— HM-CAP EIA TEST (MODIFICATION)

Substantially Equivalent

Schiff & Co.

Clearance details

Applicant: Schiff & Co.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1995-10-26
Decision date: 1996-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

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.