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 |