MODIFICATION OF EST CULTURE SYSTEM II - MYCO— 510(k) K972756
Substantially EquivalentAccumed 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.. Device class: 1.
Clearance details
- Applicant
- Accumed Intl., Inc.
- Product code
- Code MDB
- Device class
- Class 1
- Regulation
- 21 CFR 866.2560
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
Recent devices under product code MDB
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- K983309 — SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
- K983301 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
Adverse events under product code MDB
product code MDB- Death
- 6
- Malfunction
- 5,490
- Total
- 5,496
Source: openFDA MAUDE database, through . 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.