ACCESS ULTRASENSITIVE HGH CALIBRATORS— 510(k) K003098
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K003098 for ACCESS ULTRASENSITIVE HGH CALIBRATORS, Substantially Equivalent on 2000-11-20. 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
- San Diego, CA, 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.