The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Bartels Cytomegalovirus Immed. Early Antigen.
| Device ID | K904036 |
| 510k Number | K904036 |
| Device Name: | BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Tom Trotter |
| Correspondent | Tom Trotter BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-05 |
| Decision Date | 1990-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516745901 | K904036 | 000 |