ALPHA DX SYSTEM
FDA 510(k) clearance K010562 · decided 2001-03-13
Clearance details
- K-number
- K010562
- Device name
- ALPHA DX SYSTEM
- Applicant
- First Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-26
- Decision date
- 2001-03-13
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.