DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE
FDA 510(k) clearance K850986 · decided 1985-04-01
Clearance details
- K-number
- K850986
- Device name
- DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE
- Applicant
- Data Medical Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-11
- Decision date
- 1985-04-01
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- CEO
- Device class
- 1
- Regulation number
- 862.1580
- 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.