IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
FDA 510(k) clearance K000463 · decided 2000-06-01
Clearance details
- K-number
- K000463
- Device name
- IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-11
- Decision date
- 2000-06-01
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit) recall (Z-1219-03) | Diagnostic Products Corp | 2003-09-11 |