GLYCOMARK
Assay, 1,5-anhydroglucitol (15ag)
TOMEN AMERICA INC.
The following data is part of a premarket notification filed by Tomen America Inc. with the FDA for Glycomark.
Pre-market Notification Details
| Device ID | K031604 |
| 510k Number | K031604 |
| Device Name: | GLYCOMARK |
| Classification | Assay, 1,5-anhydroglucitol (15ag) |
| Applicant | TOMEN AMERICA INC. 1285 AVENUE OF THE AMERICAS New York, NY 10019 -6028 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati TOMEN AMERICA INC. 1285 AVENUE OF THE AMERICAS New York, NY 10019 -6028 |
| Product Code | NOZ |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-22 |
| Decision Date | 2003-09-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987170775586 | K031604 | 000 |
| 04987170775579 | K031604 | 000 |
| 04987170775562 | K031604 | 000 |
Trademark Results [GLYCOMARK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLYCOMARK 78183185 2918032 Live/Registered |
TOYOTA TSUSHO AMERICA INC. 2002-11-08 |
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