IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
FDA 510(k) clearance K011505 · decided 2001-07-02
Clearance details
- K-number
- K011505
- Device name
- IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-16
- Decision date
- 2001-07-02
- Days to decision
- 47 days
- Clearance type
- Traditional
- 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
No recalls on record reference this clearance.