STAT PROFILE M7 ANALYZER
FDA 510(k) clearance K991727 · decided 1999-07-16
Clearance details
- K-number
- K991727
- Device name
- STAT PROFILE M7 ANALYZER
- Applicant
- Nova Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-20
- Decision date
- 1999-07-16
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- CGL
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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| I-STAT SYSTEM (K973292) | I-Stat Corp. | 1997-10-20 |
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Recalls involving this device
No recalls on record reference this clearance.