The following data is part of a premarket notification filed by Denka Seiken's with the FDA for Mrsa-screen.
| Device ID | K011400 |
| 510k Number | K011400 |
| Device Name: | MRSA-SCREEN |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| 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 | MYI |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2002-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576021840 | K011400 | 000 |