The following data is part of a premarket notification filed by Unistrip Technologies, Llc with the FDA for Unistrip 1.
| Device ID | K113135 |
| 510k Number | K113135 |
| Device Name: | UNISTRIP 1 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | UNISTRIP TECHNOLOGIES, LLC 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith UNISTRIP TECHNOLOGIES, LLC 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2013-11-06 |
| Summary: | summary |