BITEK(TM) BLOOD CULTURE SYSTEM— 510(k) K875273

Substantially Equivalent

Definitive Diagnostics, Inc.

FDA 510(k) clearance K875273 for BITEK(TM) BLOOD CULTURE SYSTEM, Substantially Equivalent on 1988-01-22. Applicant: Definitive Diagnostics, Inc..

Clearance details

Applicant: Definitive Diagnostics, Inc.
Product code: Code JSG
Advisory panel: Microbiology
Date received: 1987-12-24
Decision date: 1988-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tualatin, OR, US

Download summary PDF View on FDA.gov ↗

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.