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 |