IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
FDA 510(k) clearance K993251 · decided 1999-11-17
Clearance details
- K-number
- K993251
- Device name
- IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-28
- Decision date
- 1999-11-17
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- LIG
- Device class
- 2
- Regulation number
- 862.1810
- 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 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186. recall (Z-0537-05) | Diagnostic Products Corp | 2005-02-11 |