G-MARK
Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae
BAINBRIDGE LABORATORIES, INC.
The following data is part of a premarket notification filed by Bainbridge Laboratories, Inc. with the FDA for G-mark.
Pre-market Notification Details
| Device ID | K880076 |
| 510k Number | K880076 |
| Device Name: | G-MARK |
| Classification | Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae |
| Applicant | BAINBRIDGE LABORATORIES, INC. 7861 DAY RD. WEST Bainbridge Island, WA 98110 |
| Contact | Stefan L Packell |
| Correspondent | Stefan L Packell BAINBRIDGE LABORATORIES, INC. 7861 DAY RD. WEST Bainbridge Island, WA 98110 |
| Product Code | LIC |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-11 |
| Decision Date | 1988-07-01 |
Trademark Results [G-MARK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 G-MARK 88131899 5745053 Live/Registered |
Liang Tianxi 2018-09-26 |
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