POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
FDA 510(k) clearance K854108 · decided 1985-11-12
Clearance details
- K-number
- K854108
- Device name
- POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
- Applicant
- Medical Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-08
- Decision date
- 1985-11-12
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- LHL
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Augusta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.