MODIFICATION OF EST CULTURE SYSTEM II - MYCO— 510(k) K972756

Substantially Equivalent

Accumed Intl., Inc.

FDA 510(k) clearance K972756 for MODIFICATION OF EST CULTURE SYSTEM II - MYCO, Substantially Equivalent on 1997-08-01. Applicant: Accumed Intl., Inc..

Clearance details

Applicant: Accumed Intl., Inc.
Product code: Code MDB
Advisory panel: Microbiology
Date received: 1997-05-30
Decision date: 1997-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, US

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Adverse events under product code MDB

product code MDB

Death: 6
Malfunction: 5,490
Total: 5,496

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.