VANCOMYCIN FLUORESCENT IMMUNOASSAY— 510(k) K822308
Substantially EquivalentAmerican Diagnostic Corp.
FDA 510(k) clearance K822308 for VANCOMYCIN FLUORESCENT IMMUNOASSAY, Substantially Equivalent on 1982-08-16. Applicant: American Diagnostic Corp.. Device class: 2.
Clearance details
- Applicant
- American Diagnostic Corp.
- Product code
- Code LEH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3950
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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