The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Fujirebio Diagnostics Ca 19-9 Ria.
Device ID | K020566 |
510k Number | K020566 |
Device Name: | FUJIREBIO DIAGNOSTICS CA 19-9 RIA |
Classification | System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
Contact | Daniel J O'shannessy |
Correspondent | Daniel J O'shannessy FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
Product Code | NIG |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-20 |
Decision Date | 2002-05-09 |
Summary: | summary |