IMMULITE CEA
FDA 510(k) clearance K970877 · decided 1997-09-22
Clearance details
- K-number
- K970877
- Device name
- IMMULITE CEA
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-10
- Decision date
- 1997-09-22
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- DHX
- 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 CEA recall (Z-1678-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |
| Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303 recall (Z-1015-05) | Diagnostic Products Corp | 2005-07-16 |
| Immulite 1000 CEA Catalog No. LKCE1 recall (Z-0972-04) | Diagnostic Products Corp | 2004-07-20 |