LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
FDA 510(k) clearance K102700 · decided 2010-12-21
Clearance details
- K-number
- K102700
- Device name
- LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
- Applicant
- Alere, San Diego, Dba Biosite INcorporated, Dba IN
- Decision
- Substantially Equivalent
- Date received
- 2010-09-20
- Decision date
- 2010-12-21
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alere
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor t recall (Z-0122-2016) | Alere San Diego, Inc. | 2015-10-15 |
| Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholest recall (Z-0746-2013) | Alere San Diego, Inc. | 2013-01-29 |
| Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cho recall (Z-0747-2013) | Alere San Diego, Inc. | 2013-01-29 |