AMMONIA/ALCOHOL CONTROL SET
FDA 510(k) clearance K070504 · decided 2007-04-11
Clearance details
- K-number
- K070504
- Device name
- AMMONIA/ALCOHOL CONTROL SET
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2007-02-21
- Decision date
- 2007-04-11
- Days to decision
- 49 days
- Clearance type
- Abbreviated
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lincoln Park, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.