The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Modification To Seraquest Eb Vca Igg.
| Device ID | K033915 |
| 510k Number | K033915 |
| Device Name: | MODIFICATION TO SERAQUEST EB VCA IGG |
| Classification | Epstein-barr Virus, Other |
| Applicant | QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami, FL 33181 |
| Contact | Robert A Cort |
| Correspondent | Robert A Cort QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami, FL 33181 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-18 |
| Decision Date | 2004-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816057020645 | K033915 | 000 |
| 00847865010795 | K033915 | 000 |