IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
FDA 510(k) clearance K013984 · decided 2002-03-28
Clearance details
- K-number
- K013984
- Device name
- IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-03
- Decision date
- 2002-03-28
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- MOI
- Device class
- 2
- Regulation number
- 866.6010
- 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
| Record | Firm | Date |
|---|---|---|
| IMMULITE /IMMULITE 1000 BR-MA (CA15-3) recall (Z-1677-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |
| IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3) recall (Z-1691-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |