SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC— 510(k) K851249

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K851249 for SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC, Substantially Equivalent on 1985-04-22. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JSJ
Advisory panel: Microbiology
Date received: 1985-03-27
Decision date: 1985-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, US

Download summary PDF View on FDA.gov ↗

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.