IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
FDA 510(k) clearance K991796 · decided 1999-06-09
Clearance details
- K-number
- K991796
- Device name
- IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-26
- Decision date
- 1999-06-09
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- DDR
- Device class
- 2
- Regulation number
- 866.5680
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.