LEECO E2 QUANT DIAG. TEST KIT
FDA 510(k) clearance K834586 · decided 1984-03-09
Clearance details
- K-number
- K834586
- Device name
- LEECO E2 QUANT DIAG. TEST KIT
- Applicant
- Leeco Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-29
- Decision date
- 1984-03-09
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- CHP
- Device class
- 1
- Regulation number
- 862.1260
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Leeco Diagnostics
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.