FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHADEBACT CSF POSITIVE CONTROLS
K Number: K840048
·
Decision Mar 2, 1984
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
41
Applicant Total
129
Review Days
56
Basic Information
- Device Name
- PHADEBACT CSF POSITIVE CONTROLS
- K Number
- K840048
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- PHARMACIA, INC.
- Date Received
- January 6, 1984
- Decision Date
- March 2, 1984
- Product Code
- GTY
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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