FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
ANTIGENZ CHLAMYDIA
K Number: K905402
·
Decision Mar 11, 1991
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
138
Applicant Total
1
Review Days
98
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Basic Information
- Device Name
- ANTIGENZ CHLAMYDIA
- K Number
- K905402
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Northumbria Biologicals , Ltd.
- Date Received
- December 3, 1990
- Decision Date
- March 11, 1991
- Product Code
- GZB
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | FDA class 2 | Neurology |
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