The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Ebv Ea-d Igg Test.
| Device ID | K091260 |
| 510k Number | K091260 |
| Device Name: | SERAQUEST EBV EA-D IGG TEST |
| Classification | Epstein-barr Virus, Other |
| Applicant | QUEST INTL., INC. 8127 N.W. 29TH STREET Doral, FL 33122 |
| Contact | David J Kiefer |
| Correspondent | David J Kiefer QUEST INTL., INC. 8127 N.W. 29TH STREET Doral, FL 33122 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-29 |
| Decision Date | 2009-06-08 |
| Summary: | summary |