FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONTRAK TESTCUP PRO-5, MODEL 1986678
K Number: K001356
·
Decision Jul 10, 2000
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
30
Applicant Total
264
Review Days
73
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Basic Information
- Device Name
- ONTRAK TESTCUP PRO-5, MODEL 1986678
- K Number
- K001356
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- April 28, 2000
- Decision Date
- July 10, 2000
- Product Code
- DJC
- 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 |
|---|---|---|---|
| DJC | Thin Layer Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
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