The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Sefria Pcp Oral Fluid Enzyme Immunoassay.
| Device ID | K181135 |
| 510k Number | K181135 |
| Device Name: | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Contact | Wenying (jessica) Zhu |
| Correspondent | Michelle Bodien Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Product Code | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2019-01-24 |
| Summary: | summary |