IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
FDA 510(k) clearance K023304 · decided 2002-12-09
Clearance details
- K-number
- K023304
- Device name
- IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-03
- Decision date
- 2002-12-09
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- JKR
- Device class
- 2
- Regulation number
- 862.1140
- 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 Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 recall (Z-0212-2015) | Siemens Healthcare Diagnostics, Inc. | 2014-11-13 |