The following data is part of a premarket notification filed by Denka Seiken's with the FDA for Vtec-rpla Seiken.
| Device ID | K981734 |
| 510k Number | K981734 |
| Device Name: | VTEC-RPLA SEIKEN |
| Classification | Antisera, All Types, Escherichia Coli |
| Applicant | DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo, JP 103-0025 |
| Contact | Kevin Mangan |
| Correspondent | Kevin Mangan DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo, JP 103-0025 |
| Product Code | GNA |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-18 |
| Decision Date | 1998-09-22 |
| Summary: | summary |