The following data is part of a premarket notification filed by Colony Laboratories, Inc. with the FDA for Fpr Phenytoin Kit.
Device ID | K894527 |
510k Number | K894527 |
Device Name: | FPR PHENYTOIN KIT |
Classification | Radioimmunoassay, Diphenylhydantoin |
Applicant | COLONY LABORATORIES, INC. 1220 NINETEENTH STREET, N.W. FOURTH FLOOR Washington, DC 20036 |
Contact | Dale B Hinson |
Correspondent | Dale B Hinson COLONY LABORATORIES, INC. 1220 NINETEENTH STREET, N.W. FOURTH FLOOR Washington, DC 20036 |
Product Code | DLP |
CFR Regulation Number | 862.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-20 |
Decision Date | 1989-09-25 |