The following data is part of a premarket notification filed by Sekisui Diagnostics P.e.i. Inc. with the FDA for Dc-uibc-cal.
| Device ID | K163078 |
| 510k Number | K163078 |
| Device Name: | DC-UIBC-CAL |
| Classification | Calibrator, Secondary |
| Applicant | SEKISUI DIAGNOSTICS P.E.I. INC. 70 WATTS AVENUE Charlottetown, CA C1e 2b9 |
| Contact | Penny White |
| Correspondent | Penny White SEKISUI DIAGNOSTICS P.E.I. INC. 70 WATTS AVENUE Charlottetown, CA C1e 2b9 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-03 |
| Decision Date | 2016-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063401024 | K163078 | 000 |