The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Teco Diagnostics Saliva Alcohol Test.
| Device ID | K111206 |
| 510k Number | K111206 |
| Device Name: | TECO DIAGNOSTICS SALIVA ALCOHOL TEST |
| Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | James Li |
| Correspondent | James Li TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | DIC |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-29 |
| Decision Date | 2011-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816862025385 | K111206 | 000 |
| 10816862020387 | K111206 | 000 |
| B298409000 | K111206 | 000 |
| B2984090010 | K111206 | 000 |
| 10816862022336 | K111206 | 000 |
| 10816862022992 | K111206 | 000 |
| 10673486000993 | K111206 | 000 |
| 10816862024538 | K111206 | 000 |