The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Anti-sm/rnp.
| Device ID | K980811 |
| 510k Number | K980811 |
| Device Name: | SERAQUEST ANTI-SM/RNP |
| Classification | Anti-sm Antibody, Antigen And Control |
| 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 | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-03 |
| Decision Date | 1998-05-12 |
| Summary: | summary |