The following data is part of a premarket notification filed by Cenogenics Corp. with the FDA for Monodex.
Device ID | K894793 |
510k Number | K894793 |
Device Name: | MONODEX |
Classification | System, Test, Infectious Mononucleosis |
Applicant | CENOGENICS CORP. 620 ROUTE 520 Morganville, NJ 07751 |
Contact | Michael Katz |
Correspondent | Michael Katz CENOGENICS CORP. 620 ROUTE 520 Morganville, NJ 07751 |
Product Code | KTN |
CFR Regulation Number | 866.5640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-28 |
Decision Date | 1989-08-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MONODEX 74051999 1668979 Dead/Cancelled |
WHITEHEAD LETTERFILES LTD. 1990-04-23 |
MONODEX 73608572 1431318 Dead/Cancelled |
DAIWA GOLF CO., LTD. 1986-07-09 |
MONODEX 73091588 1076386 Dead/Cancelled |
Monodex Business Systems Limited 1976-06-25 |
MONODEX 73062799 1035707 Dead/Expired |
OAK INDUSTRIES INC. 1975-09-11 |
MONODEX 71571608 0532391 Dead/Expired |
GENERAL ANILINE & FILM CORPORATION 1949-01-04 |