FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
K Number: K990409
·
Decision Apr 15, 1999
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
264
Review Days
65
Basic Information
- Device Name
- ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
- K Number
- K990409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3640
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ROCHE DIAGNOSTICS CORP.
- Date Received
- February 9, 1999
- Decision Date
- April 15, 1999
- Product Code
- DMY
- 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 |
|---|---|---|---|
| DMY | Gas Chromatography, Morphine | FDA class 2 | Clinical Toxicology |
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