The following data is part of a premarket notification filed by Stellar Bio Systems, Inc. with the FDA for Epstein-barr Virus Early Antigen (ebv-ea) Igg Ifa Test System.
| Device ID | K992587 |
| 510k Number | K992587 |
| Device Name: | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM |
| Classification | Epstein-barr Virus, Other |
| Applicant | STELLAR BIO SYSTEMS, INC. 9075 GUILFORD RD. Columbia, MD 21046 |
| Contact | John Brewer |
| Correspondent | John Brewer STELLAR BIO SYSTEMS, INC. 9075 GUILFORD RD. Columbia, MD 21046 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-02 |
| Decision Date | 1999-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545025618 | K992587 | 000 |
| 00813545025595 | K992587 | 000 |