IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
FDA 510(k) clearance K033234 · decided 2003-12-12
Clearance details
- K-number
- K033234
- Device name
- IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-06
- Decision date
- 2003-12-12
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- DHA
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150 recall (Z-1033-2010) | Siemens Healthcare Diagnostics Inc. | 2010-03-10 |
| Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Perfor recall (Z-1399-2009) | Siemens Medical Solutions Diagnostics | 2009-05-26 |
| Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test syste recall (Z-0263-05) | DPC Cirrus | 2004-11-30 |