The following data is part of a premarket notification filed by Shasta Technologies, Llc with the FDA for Genstrip Test Strip Model 100-201.
| Device ID | K103542 |
| 510k Number | K103542 |
| Device Name: | GENSTRIP TEST STRIP MODEL 100-201 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | SHASTA TECHNOLOGIES, LLC 611 W 5TH ST. 3RD FLOOR Austin, TX 78701 |
| Contact | Caroline Tontini |
| Correspondent | Caroline Tontini SHASTA TECHNOLOGIES, LLC 611 W 5TH ST. 3RD FLOOR Austin, TX 78701 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-02 |
| Decision Date | 2012-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002137971 | K103542 | 000 |
| 20860002137968 | K103542 | 000 |
| 20860002137937 | K103542 | 000 |
| 10860002137923 | K103542 | 000 |
| 00850015460036 | K103542 | 000 |