The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Eb Na Igg.
Device ID | K991975 |
510k Number | K991975 |
Device Name: | SERAQUEST EB NA 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-11 |
Decision Date | 1999-11-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816057020638 | K991975 | 000 |
00847865010788 | K991975 | 000 |