FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPIDTEST-HCG (TM)
K Number: K883235
·
Decision Sep 30, 1988
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
3
Review Days
60
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Basic Information
- Device Name
- RAPIDTEST-HCG (TM)
- K Number
- K883235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Synbiotics Corp.
- Date Received
- August 1, 1988
- Decision Date
- September 30, 1988
- Product Code
- DHA
- 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 |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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