ONTRAK TESTCUP PRO-5, MODEL 1986678
FDA 510(k) clearance K001356 · decided 2000-07-10
Clearance details
- K-number
- K001356
- Device name
- ONTRAK TESTCUP PRO-5, MODEL 1986678
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-28
- Decision date
- 2000-07-10
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- DJC
- Device class
- 2
- Regulation number
- 862.3610
- 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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