The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Cellognost Syphilis H.
| Device ID | K896410 |
| 510k Number | K896410 |
| Device Name: | CELLOGNOST SYPHILIS H |
| Classification | Antigens, Ha, Treponema Pallidum |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | GMT |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-07 |
| Decision Date | 1990-05-15 |