The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Cyfra 21-1 Eia Model 211-10.
Device ID | K100831 |
510k Number | K100831 |
Device Name: | CYFRA 21-1 EIA MODEL 211-10 |
Classification | Cytokeratin Fragments 21-1 Eia Kit |
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 | OVK |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-24 |
Decision Date | 2011-05-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17350066140135 | K100831 | 000 |