The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Architect He4, Architect He4 Calibrators And Architect He4 Controls, Models 2, 2p54, 2p54-01, 2p54-10 Sp54-01,.
Device ID | K093957 |
510k Number | K093957 |
Device Name: | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, |
Classification | Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
Applicant | FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern, PA 19355 -1307 |
Contact | Stacey Dolan |
Correspondent | Stacey Dolan FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern, PA 19355 -1307 |
Product Code | OIU |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-23 |
Decision Date | 2010-03-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00380740138349 | K093957 | 000 |
00380740048433 | K093957 | 000 |
00380740003982 | K093957 | 000 |
00380740003975 | K093957 | 000 |