FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
K Number: K981341
·
Decision May 22, 1998
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
30
Review Days
39
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Basic Information
- Device Name
- STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
- K Number
- K981341
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OraSure Technologies, Inc.
- Date Received
- April 13, 1998
- Decision Date
- May 22, 1998
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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