FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K Number: K031004
·
Decision Jun 6, 2003
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
343
Review Days
67
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Basic Information
- Device Name
- SYVA EMIT II PLUS AMPHETAMINES ASSAY
- K Number
- K031004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- March 31, 2003
- Decision Date
- June 6, 2003
- Product Code
- DKZ
- 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | FDA class 2 | Clinical Toxicology |
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