The following data is part of a premarket notification filed by Denka Seiken Co., Ltd. with the FDA for Archiect Insulin And Controls, Model 8k41-01, 8k41-10.
| Device ID | K060359 |
| 510k Number | K060359 |
| Device Name: | ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 |
| Classification | Calibrator, Secondary |
| Applicant | DENKA SEIKEN CO., LTD. 1-2-2, MINAMI HON CHO Gosen-shi, Niigata, JP 959-1695 |
| Contact | Toshimi Matsunaga |
| Correspondent | Toshimi Matsunaga DENKA SEIKEN CO., LTD. 1-2-2, MINAMI HON CHO Gosen-shi, Niigata, JP 959-1695 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740017545 | K060359 | 000 |
| 00380740017521 | K060359 | 000 |