FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NABI CRP-Q.S. TEST
K Number: K834584
·
Decision Feb 27, 1984
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
6
Review Days
60
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Basic Information
- Device Name
- NABI CRP-Q.S. TEST
- K Number
- K834584
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Diagnostic, Inc.
- Date Received
- December 29, 1983
- Decision Date
- February 27, 1984
- Product Code
- DCN
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
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|---|---|---|---|
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| K802343 | PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO | Oct 10, 1980 | Substantially Equivalent |
| K780321 | PREGNANCY TEST KIT, OVER-THE-COUNTER | Apr 4, 1978 | Substantially Equivalent |