ACCESS OSTASE IMMUNOENZYMETRIC ASSAY— 510(k) K994278
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K994278 for ACCESS OSTASE IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 2000-03-28. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code CIN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code CIN
view allMore clearances from Beckman Coulter, Inc.
view allRecalls naming K994278
K-number listed on FDA's recall record- Z-0407-2017 — Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
- Z-0408-2017 — Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994278.
Data sourced from openFDA. This site is unofficial and independent of the FDA.