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 |