IL TEST BETA-2MICROGLOBULIN
FDA 510(k) clearance K943686 · decided 1995-05-15
Clearance details
- K-number
- K943686
- Device name
- IL TEST BETA-2MICROGLOBULIN
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1994-07-29
- Decision date
- 1995-05-15
- Days to decision
- 290 days
- Clearance type
- Traditional
- Product code
- JZG
- Device class
- 2
- Regulation number
- 866.5630
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.