FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
K Number: K013882
·
Decision Apr 17, 2002
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
89
Applicant Total
30
Review Days
145
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Basic Information
- Device Name
- OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
- K Number
- K013882
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3170
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OraSure Technologies, Inc.
- Date Received
- November 23, 2001
- Decision Date
- April 17, 2002
- Product Code
- JXM
- 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 |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | FDA class 2 | Clinical Toxicology |
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