FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEGIONELLA CULTURE CONFIRMATIN KIT
K Number: K851271
·
Decision Jul 8, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
62
Review Days
98
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Basic Information
- Device Name
- LEGIONELLA CULTURE CONFIRMATIN KIT
- K Number
- K851271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Gen-Probe, Inc.
- Date Received
- April 1, 1985
- Decision Date
- July 8, 1985
- Product Code
- GRO
- 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 |
|---|---|---|---|
| GRO | Antisera, Fluorescent, All Types, Hemophilus Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GRO), ordered by most recent decision date.
LEGIONELLA DIFFERENTIATION DISK
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PHADEBACT HAEMOPHILUS TEST
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BACTOGEN-H. INFLUENZAE TYPE B
FDA 510(k)
FDA Class 2
·Microbiology
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