SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE— 510(k) K812729

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K812729 for SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE, Substantially Equivalent on 1981-10-19. Applicant: Hoffmann-La Roche, Inc..

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code JSG
Advisory panel: Microbiology
Date received: 1981-09-28
Decision date: 1981-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JSG

product code JSG

Malfunction: 817
Total: 817

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.