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 |