CHOLESTEROL 1, 2, 3
FDA 510(k) clearance K014018 · decided 2002-06-24
Clearance details
- K-number
- K014018
- Device name
- CHOLESTEROL 1, 2, 3
- Applicant
- Imi
- Decision
- Unknown
- Date received
- 2001-12-06
- Decision date
- 2002-06-24
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- LBS
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Imi
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.