IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
FDA 510(k) clearance K013566 · decided 2001-11-20
Clearance details
- K-number
- K013566
- Device name
- IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-26
- Decision date
- 2001-11-20
- Days to decision
- 25 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 |
|---|---|---|
| Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 103814 recall (Z-0366-2026) | Siemens Healthcare Diagnostics, Inc. | 2025-10-27 |
| IMMULITE 2000 Intact PTH kit recall (Z-0724-04) | Diagnostic Products Corp | 2004-07-20 |