The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Is Ebv-ebna-1 Igg Elisa Test System.
| Device ID | K981829 |
| 510k Number | K981829 |
| Device Name: | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM |
| Classification | Antiserum, Cf, Epstein-barr Virus |
| Applicant | DIAMEDIX CORP. 8775 M CENTRE PARK DR. #559 Columbia, MD 21045 |
| Contact | Norman Jenkins |
| Correspondent | Norman Jenkins DIAMEDIX CORP. 8775 M CENTRE PARK DR. #559 Columbia, MD 21045 |
| Product Code | GNP |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-22 |
| Decision Date | 1999-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3507206200 | K981829 | 000 |