ACCESS UNCONJUGATED ESTRIOL CALIBRATORS— 510(k) K012900
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K012900 for ACCESS UNCONJUGATED ESTRIOL CALIBRATORS, Substantially Equivalent on 2001-10-16. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code JIT
view allMore clearances from Beckman Coulter, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.