FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
K Number: K890721
·
Decision Apr 10, 1989
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
4
Applicant Total
4
Review Days
56
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Basic Information
- Device Name
- SHAPE-ACTIO METAL TOXICOLOGY CONTROL
- K Number
- K890721
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Actio, Inc.
- Date Received
- February 13, 1989
- Decision Date
- April 10, 1989
- Product Code
- DIE
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DIE | Heavy Metals Control Materials | FDA class 1 | Clinical Toxicology |
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