AVL 9181 ELECTROLYTE ANALYZER
FDA 510(k) clearance K972673 · decided 1997-08-20
Clearance details
- K-number
- K972673
- Device name
- AVL 9181 ELECTROLYTE ANALYZER
- Applicant
- Avl Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-16
- Decision date
- 1997-08-20
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JFP
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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