SABOURAUD DEXTROSE AGAR— 510(k) K811325
Substantially EquivalentAcumedia Manufacturers, Inc.
FDA 510(k) clearance K811325 for SABOURAUD DEXTROSE AGAR, Substantially Equivalent on 1981-05-28. Applicant: Acumedia Manufacturers, Inc.. Device class: 1.
Clearance details
- Applicant
- Acumedia Manufacturers, Inc.
- Product code
- Code JSJ
- Device class
- Class 1
- Regulation
- 21 CFR 866.2360
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JSJ
view allMore clearances from Acumedia Manufacturers, Inc.
view allAdverse events under product code JSJ
product code JSJ- Malfunction
- 520
- Total
- 520
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.