The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Capture-cmv.
| Device ID | K183571 |
| 510k Number | K183571 |
| Device Name: | Capture-CMV |
| Classification | Antigen, Iha, Cytomegalovirus |
| Applicant | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
| Contact | Howard Yorek |
| Correspondent | Howard Yorek Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
| Product Code | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-02-04 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CAPTURE-CMV 74179110 1695744 Live/Registered |
IMMUCOR, INC. 1991-06-24 |