LDL CHOLESTEROL (AUTOMATED)
FDA 510(k) clearance K022519 · decided 2002-09-30
Clearance details
- K-number
- K022519
- Device name
- LDL CHOLESTEROL (AUTOMATED)
- Applicant
- Jas Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-30
- Decision date
- 2002-09-30
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- JHM
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BS-200 Chemistry Analyzer Designed for clinical laboratory use. recall (Z-0977-2013) | Mindray DS USA, Inc. d.b.a. Mindray North America | 2013-03-22 |