The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Roma.
Device ID | K160090 |
510k Number | K160090 |
Device Name: | Lumipulse G ROMA |
Classification | Ovarian Adnexal Mass Assessment Score Test System |
Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
Contact | Diana Dickson |
Correspondent | Diana Dickson Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
Product Code | ONX |
CFR Regulation Number | 866.6050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-15 |
Decision Date | 2016-05-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00869164000024 | K160090 | 000 |
00869164000017 | K160090 | 000 |