The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Ethanol-l3k Assay, Models 273-30, 273-17, 273-10.
| Device ID | K001286 |
| 510k Number | K001286 |
| Device Name: | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 |
| Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, CA C1e 2a6 |
| Product Code | DIC |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-21 |
| Decision Date | 2000-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063401086 | K001286 | 000 |
| 00628063400492 | K001286 | 000 |