The following data is part of a premarket notification filed by Sendx Medical Inc with the FDA for Abl80 Flex And Abl80 Flex Co-ox.
| Device ID | K151639 |
| 510k Number | K151639 |
| Device Name: | ABL80 FLEX And ABL80 FLEX CO-OX |
| Classification | Glucose Oxidase, Glucose |
| Applicant | SENDX MEDICAL INC 1945 PALOMAR OAKS WAY Carlsbad, CA 92011 |
| Contact | Vibeke Agerlin |
| Correspondent | Soren Bogestrand RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK 2700 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-18 |
| Decision Date | 2015-12-07 |
| Summary: | summary |