The following data is part of a premarket notification filed by Chematics, Inc. with the FDA for Alco-screen 02.
| Device ID | K121256 |
| 510k Number | K121256 |
| Device Name: | ALCO-SCREEN 02 |
| Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Applicant | CHEMATICS, INC. P.O. BOX 293 HIGHWAY 13 SOUTH North Webster, IN 46555 |
| Contact | Carl Reynolds |
| Correspondent | Carl Reynolds CHEMATICS, INC. P.O. BOX 293 HIGHWAY 13 SOUTH North Webster, IN 46555 |
| Product Code | DIC |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-25 |
| Decision Date | 2012-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00737051863109 | K121256 | 000 |