FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIRECT FA CONJUGATE FOR LEGIONELLA SPP
K Number: K822859
·
Decision Feb 16, 1983
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
17
Applicant Total
4
Review Days
142
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Basic Information
- Device Name
- DIRECT FA CONJUGATE FOR LEGIONELLA SPP
- K Number
- K822859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Zeus Technologies
- Date Received
- September 27, 1982
- Decision Date
- February 16, 1983
- Product Code
- LHL
- 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 |
|---|---|---|---|
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | FDA class 2 | Microbiology |
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