The following data is part of a premarket notification filed by Immuno Probe, Inc. with the FDA for Ebna Igg Eia Test System.
| Device ID | K951549 |
| 510k Number | K951549 |
| Device Name: | EBNA IGG EIA TEST SYSTEM |
| Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
| Applicant | IMMUNO PROBE, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Contact | Edward C Wilson, Jr. |
| Correspondent | Edward C Wilson, Jr. IMMUNO PROBE, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Product Code | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-04 |
| Decision Date | 1996-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747097 | K951549 | 000 |
| 05391516743570 | K951549 | 000 |
| 05391516746571 | K951549 | 000 |