The following data is part of a premarket notification filed by The Du Pont Co. with the FDA for Analyst Theophylline Rotor.
| Device ID | K884002 |
| 510k Number | K884002 |
| Device Name: | ANALYST THEOPHYLLINE ROTOR |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | THE DU PONT CO. CHESTNUT RUN PLAZA P.O. BOX 80715 Wilmington, DE |
| Contact | M Vaught |
| Correspondent | M Vaught THE DU PONT CO. CHESTNUT RUN PLAZA P.O. BOX 80715 Wilmington, DE |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-21 |
| Decision Date | 1988-10-31 |