The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Rubella Igg.
Device ID | K961053 |
510k Number | K961053 |
Device Name: | SERAQUEST RUBELLA IGG |
Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
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 | LFX |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-18 |
Decision Date | 1996-09-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811727015174 | K961053 | 000 |
00816057020515 | K961053 | 000 |
00847865010689 | K961053 | 000 |