FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ONTRAK TESTCUP 5, CAT. 07 6481 7
K Number: K994030
·
Decision Jan 27, 2000
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
87
Applicant Total
264
Review Days
62
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Basic Information
- Device Name
- ONTRAK TESTCUP 5, CAT. 07 6481 7
- K Number
- K994030
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- November 26, 1999
- Decision Date
- January 27, 2000
- Product Code
- LCM
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | FDA unclassified | Unknown |
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