FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHADEBACT CSF TEST 20
K Number: K822810
·
Decision Dec 30, 1982
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
15
Applicant Total
129
Review Days
101
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Basic Information
- Device Name
- PHADEBACT CSF TEST 20
- K Number
- K822810
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- September 20, 1982
- Decision Date
- December 30, 1982
- Product Code
- GTJ
- 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 |
|---|---|---|---|
| GTJ | Antisera, All Groups, N. Meningitidis | FDA class 2 | Microbiology |
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| K962274 | UNICAP 100 | Sep 12, 1996 | Substantially Equivalent |
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| K954337 | GENOTROPIN MIXER | Nov 13, 1995 | Substantially Equivalent |
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