The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Anti-thyroid Peroxidase (tpo).
| Device ID | K023593 |
| 510k Number | K023593 |
| Device Name: | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) |
| Classification | System, Test, Thyroid Autoantibody |
| 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 | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-25 |
| Decision Date | 2003-02-06 |
| Summary: | summary |