ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
FDA 510(k) clearance K020575 · decided 2002-04-12
Clearance details
- K-number
- K020575
- Device name
- ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
- Applicant
- Elan Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2002-02-21
- Decision date
- 2002-04-12
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- MRR
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Elan Diagnostics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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
No recalls on record reference this clearance.