FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
K Number: K982061
·
Decision Aug 25, 1998
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
30
Review Days
82
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Basic Information
- Device Name
- STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
- K Number
- K982061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OraSure Technologies, Inc.
- Date Received
- June 4, 1998
- Decision Date
- August 25, 1998
- Product Code
- DIO
- 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
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