DRI-STAT ACID PHOSPHATASE REAGENT— 510(k) K053612
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K053612 for DRI-STAT ACID PHOSPHATASE REAGENT, Substantially Equivalent on 2006-04-26. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code CKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.1020
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Recent devices under product code CKB
view allMore clearances from Beckman Coulter, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.