ALKALINE PHOSPHATASE PROCEDURE
FDA 510(k) clearance K861667 · decided 1986-05-29
Clearance details
- K-number
- K861667
- Device name
- ALKALINE PHOSPHATASE PROCEDURE
- Applicant
- Data Medical Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-30
- Decision date
- 1986-05-29
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- CJE
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Arlington, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.