IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
FDA 510(k) clearance K980855 · decided 1998-04-21
Clearance details
- K-number
- K980855
- Device name
- IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
- Applicant
- Dpc Cirrus
- Decision
- Substantially Equivalent
- Date received
- 1998-03-05
- Decision date
- 1998-04-21
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- DHX
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Randolph, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000/IMMULITE 2000 XPi CEA recall (Z-1679-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |