#2013 CNA 5% SHEEP BLOOD— 510(k) K820804

Substantially Equivalent

Biomedica, Inc.

FDA 510(k) clearance K820804 for #2013 CNA 5% SHEEP BLOOD, Substantially Equivalent on 1982-04-08. Applicant: Biomedica, Inc..

Clearance details

Applicant: Biomedica, Inc.
Product code: Code JSJ
Advisory panel: Microbiology
Date received: 1982-03-23
Decision date: 1982-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

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.