FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACU-SLIDE TEST
K Number: K812789
·
Decision Dec 17, 1981
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
3
Review Days
73
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Basic Information
- Device Name
- ACU-SLIDE TEST
- K Number
- K812789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- C.F. Medical, Inc.
- Date Received
- October 5, 1981
- Decision Date
- December 17, 1981
- Product Code
- JHJ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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