The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Immusure.
Device ID | K973894 |
510k Number | K973894 |
Device Name: | IMMUSURE |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
Contact | Evy Johnson |
Correspondent | Evy Johnson QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-14 |
Decision Date | 1997-10-29 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() IMMUSURE 77718715 not registered Dead/Abandoned |
Diamond V Mills, Inc. 2009-04-21 |
![]() IMMUSURE 73704015 1601804 Dead/Cancelled |
CAMBRIDGE LIFE SCIENCES PLC 1988-01-04 |