The following data is part of a premarket notification filed by Immudex Aps with the FDA for Dextramer Cmv Kit.
| Device ID | K153538 |
| 510k Number | K153538 |
| Device Name: | Dextramer CMV Kit |
| Classification | Counter, Differential Cell |
| Applicant | Immudex Aps Fruebjergvej 3 Copenhagen, DK 2100 |
| Contact | Liselotte Brix |
| Correspondent | Liselotte Brix Immudex Aps Fruebjergvej 3 Copenhagen, DK 2100 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-10 |
| Decision Date | 2017-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05714183000010 | K153538 | 000 |