IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
FDA 510(k) clearance K993254 · decided 1999-11-12
Clearance details
- K-number
- K993254
- Device name
- IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-28
- Decision date
- 1999-11-12
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- CGN
- Device class
- 2
- Regulation number
- 862.1295
- 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/IMMULITE 2000 XPi Folic Acid recall (Z-1676-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |