The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Rubella Igm.
| Device ID | K982281 |
| 510k Number | K982281 |
| Device Name: | SERAQUEST RUBELLA IGM |
| 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 | 1998-06-30 |
| Decision Date | 1998-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015181 | K982281 | 000 |
| 00816057020522 | K982281 | 000 |
| 00847865010696 | K982281 | 000 |