BETA-HCG ASSAY— 510(k) K873986

Substantially Equivalent

Schiff & Co.

FDA 510(k) clearance K873986 for BETA-HCG ASSAY, Substantially Equivalent on 1988-02-02. Applicant: Schiff & Co..

Clearance details

Applicant: Schiff & Co.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1987-09-29
Decision date: 1988-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

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Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.