510(k) K994278 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
| Applicant | Beckman Coulter, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 28, 2000 |
| Received | Dec 20, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994278
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2016 | Beckman Coulter Inc. 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 Terminated |
JIS | None listed |
| Oct 24, 2016 | Beckman Coulter Inc. Access Ostase QC, Catalog No. 37309, B83877
Product Usage:
The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. Terminated |
JJX | None listed |
| Mar 21, 2012 | Beckman Coulter Inc. Access Ostase Calibrators, Part Number: 37305,
Subsequent Product Code: JIS.
The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone Terminated |
CIN | None listed |
| Mar 21, 2012 | Beckman Coulter Inc. Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS.
The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteobla Terminated |
CIN | None listed |
| Mar 9, 2012 | Beckman Coulter Inc. ACCESS Ostase
Part Number: 37300
Used for the quantitative measurement of bone alkaline phosphatase (BAP). Terminated |
CIN | None listed |
| Jun 21, 2011 | Beckman Coulter Inc. Access Immunoassay Systems
Ostase Calibrators, Part Number: 37305
The Access Ostase Calibrators are used to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosp Terminated |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.