FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
K Number: K002010
·
Decision Nov 29, 2000
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
62
Applicant Total
29
Review Days
149
Basic Information
- Device Name
- STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
- K Number
- K002010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3620
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORASURE TECHNOLOGIES, INC.
- Date Received
- July 3, 2000
- Decision Date
- November 29, 2000
- Product Code
- DJR
- 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 |
|---|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | FDA class 2 | Clinical Toxicology |
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