SYSTEMATE PHOSPHORUS 67217
FDA 510(k) clearance K843330 · decided 1984-09-14
Clearance details
- K-number
- K843330
- Device name
- SYSTEMATE PHOSPHORUS 67217
- Applicant
- Em Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-27
- Decision date
- 1984-09-14
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- CEO
- Device class
- 1
- Regulation number
- 862.1580
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.