IL TEST PHOSPHORUS
FDA 510(k) clearance K931361 · decided 1993-05-11
Clearance details
- K-number
- K931361
- Device name
- IL TEST PHOSPHORUS
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1993-03-17
- Decision date
- 1993-05-11
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- CEO
- Device class
- 1
- Regulation number
- 862.1580
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.