FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
K Number: K051794
·
Decision Aug 16, 2005
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
1
Review Days
46
Basic Information
- Device Name
- GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
- K Number
- K051794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3045
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OFFICE OF THE SURGEON GENERAL, U.S. ARMY
- Date Received
- July 1, 2005
- Decision Date
- August 16, 2005
- Product Code
- NVQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NVQ | Bacteriophage And Controls, B. Anthracis Lysis | FDA class 2 | Microbiology |
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