The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221.
| Device ID | K032461 |
| 510k Number | K032461 |
| Device Name: | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 |
| Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Applicant | Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Contact | Cheng I Lin |
| Correspondent | Cheng I Lin Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Product Code | DIC |
| Subsequent Product Code | DKC |
| Subsequent Product Code | DNN |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-11 |
| Decision Date | 2003-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07602250 | K032461 | 000 |
| 00811727017406 | K032461 | 000 |
| 00811727017413 | K032461 | 000 |
| 00811727017420 | K032461 | 000 |
| 00811727017437 | K032461 | 000 |
| B07602200 | K032461 | 000 |
| B07602210 | K032461 | 000 |
| B07602230 | K032461 | 000 |
| B07602240 | K032461 | 000 |
| 00811727017390 | K032461 | 000 |