The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Ethyl Alcohol Enzyme Assay.
| Device ID | K181553 |
| 510k Number | K181553 |
| Device Name: | Immunalysis Ethyl Alcohol Enzyme Assay |
| Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Applicant | Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Contact | Weying (jessica) Zhu |
| Correspondent | Wenying (jessica) Zhu Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Product Code | DIC |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-13 |
| Decision Date | 2018-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937110386 | K181553 | 000 |
| 00840937110379 | K181553 | 000 |
| 00840937110362 | K181553 | 000 |
| 00840937110355 | K181553 | 000 |