The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Cytomegalovirus Antibody Screen.
| Device ID | K910003 |
| 510k Number | K910003 |
| Device Name: | CYTOMEGALOVIRUS ANTIBODY SCREEN |
| Classification | Antigen, Iha, Cytomegalovirus |
| Applicant | IMMUCOR, INC. 3130 GATEWAY DR. P.O. BOX 5625 Norcross, GA 30091 -5625 |
| Contact | Ralph A Eatz |
| Correspondent | Ralph A Eatz IMMUCOR, INC. 3130 GATEWAY DR. P.O. BOX 5625 Norcross, GA 30091 -5625 |
| Product Code | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-02 |
| Decision Date | 1991-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234002154 | K910003 | 000 |
| 10888234001249 | K910003 | 000 |
| 10888234001232 | K910003 | 000 |
| 10888234001157 | K910003 | 000 |