FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHADEBACT HAEMOPHILUS TEST
K Number: K802423
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
129
Review Days
40
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Basic Information
- Device Name
- PHADEBACT HAEMOPHILUS TEST
- K Number
- K802423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- October 3, 1980
- Decision Date
- November 12, 1980
- 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 |
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