ONTRAK TESTCARD 9
FDA 510(k) clearance K012396 · decided 2001-11-05
Clearance details
- K-number
- K012396
- Device name
- ONTRAK TESTCARD 9
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-27
- Decision date
- 2001-11-05
- Days to decision
- 101 days
- Clearance type
- Abbreviated
- Product code
- DKZ
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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