FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BETA-HCG HEMAGGLUTINATION TEST
K Number: K842181
·
Decision Aug 22, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
3
Review Days
82
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Basic Information
- Device Name
- BETA-HCG HEMAGGLUTINATION TEST
- K Number
- K842181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sero-Immuno Diagnostics, Inc.
- Date Received
- June 1, 1984
- Decision Date
- August 22, 1984
- Product Code
- JHJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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