FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACU-SLIDE-TEST
K Number: K853247
·
Decision Sep 4, 1985
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
3
Review Days
34
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Basic Information
- Device Name
- ACU-SLIDE-TEST
- K Number
- K853247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cal-Tech Diagnostics, Inc.
- Date Received
- August 1, 1985
- Decision Date
- September 4, 1985
- Product Code
- JHJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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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