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 |