The following data is part of a premarket notification filed by Intracel Corp. with the FDA for Bartels Cinakit Cmv Antigenemia.
| Device ID | K982311 |
| 510k Number | K982311 |
| Device Name: | BARTELS CINAKIT CMV ANTIGENEMIA |
| Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
| Applicant | INTRACEL CORP. 1330 PICCARD DR. Rockville, MD 20850 |
| Contact | Fedora Daye Contreras |
| Correspondent | Fedora Daye Contreras INTRACEL CORP. 1330 PICCARD DR. Rockville, MD 20850 |
| Product Code | GQH |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-01 |
| Decision Date | 1998-12-14 |
| Summary: | summary |