The following data is part of a premarket notification filed by Clark Laboratories, Inc. with the FDA for Vca Igm Elisa Test System.
| Device ID | K980596 |
| 510k Number | K980596 |
| Device Name: | VCA IGM ELISA TEST SYSTEM |
| Classification | Epstein-barr Virus, Other |
| 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 | LSE |
| 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 | 1998-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747080 | K980596 | 000 |
| 05391516743556 | K980596 | 000 |
| 05391516746540 | K980596 | 000 |