IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
FDA 510(k) clearance K022603 · decided 2002-08-21
Clearance details
- K-number
- K022603
- Device name
- IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-06
- Decision date
- 2002-08-21
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- CEW
- Device class
- 2
- Regulation number
- 862.1545
- 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 --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code recall (Z-1700-2012) | Siemens Healthcare Diagnostics | 2012-06-02 |
| IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests) --- Te recall (Z-1701-2012) | Siemens Healthcare Diagnostics | 2012-06-02 |