TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY— 510(k) K870521

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K870521 for TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY, Substantially Equivalent on 1987-04-08. Applicant: Hybritech, Inc..

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1987-02-06
Decision date: 1987-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.