510(k) K143534
- Device
- Elecsys CA-125 II Assay
- Applicant
- ROCHE PROFESSIONAL DIAGNOSTICS
- 510(k) number
- K143534
- Product code
- LTK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-06
- Date received
- 2014-12-12
- Regulation
- 866.6010
- Classification name
- Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LINDA MCCAMMACK
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3004192065
- 2517506
- 2432235
- 3007111389
- 3005333358
- 3006198300
- 3002806944
- 3011989923
- 3000308930
- 3002809144
- 3002642396
- 9610126
- 8020888
- 1036362
- 3005360469
- 8031673
- 3012963943
- 2032839
- 2020726
- 2250051
- 3005622096
- 2122870
- 3002895169
- 1643621
- 3005529799
- 9612316
- 3014643041
- 2521625
- 1219913
- 1319681
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary