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 |