LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST— 510(k) K864006
Substantially EquivalentMedical Diagnostic Technologies, Inc.
FDA 510(k) clearance K864006 for LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST, Substantially Equivalent on 1987-04-20. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Diagnostic Technologies, Inc.
- Product code
- Code LHL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3300
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Augusta, GA, US
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