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 |