Panels › Clinical Chemistry › Product code CIN · Class 2
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Regulation 862.1050
0510(k)s in 12 months (26 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in CIN
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter | 2 | 3 |
| Helena Laboratories | 5 | 0 |
| Hybritech, Inc. | 3 | 0 |
| Immunodiagnostics Systems Ltd | 0 | 3 |
| Metra Biosystems, Inc. | 2 | 0 |
| Sigma Chemical Co. | 2 | 0 |
| Beckman Instruments, Inc. | 1 | 0 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Bioware Products | 1 | 0 |
| California Immuno Diagnostic, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2016 | Diagnostic Hybrids, Inc. MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum. Terminated |
CIN | K981373 |
| Oct 10, 2012 | Immunodiagnostics Systems Ltd IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles.
The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended Terminated |
CIN | None listed |
| Oct 10, 2012 | Immunodiagnostics Systems Ltd IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles.
The IDS-iSYS Ostase BAP (IDS-iSYS BAP) Control Set is used fo Terminated |
CIN | None listed |
| Oct 10, 2012 | Immunodiagnostics Systems Ltd IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles.
The IDS-iSYS Ostase BAP Assay (IDS-iSYS BAP) is intended for the quantita 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 | K994278 |
| 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 | K994278 |
| Mar 9, 2012 | Beckman Coulter Inc. ACCESS Ostase
Part Number: 37300
Used for the quantitative measurement of bone alkaline phosphatase (BAP). Terminated |
CIN | K994278 |
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