The following data is part of a premarket notification filed by Clark Laboratories, Inc. with the FDA for Ebna-1 Igm Elisa Test System.
| Device ID | K980598 |
| 510k Number | K980598 |
| Device Name: | EBNA-1 IGM ELISA TEST SYSTEM |
| Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
| Applicant | CLARK LABORATORIES, INC. 1306F BAILES LN. Frederick, MD 21701 |
| Contact | William L Boteler, Jr. |
| Correspondent | William L Boteler, Jr. CLARK LABORATORIES, INC. 1306F BAILES LN. Frederick, MD 21701 |
| Product Code | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747103 | K980598 | 000 |
| 05391516743587 | K980598 | 000 |