The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Pcp Urine Enzyme Immunoassay, Immunalysis Multi-drug Calibrators.
| Device ID | K152176 |
| 510k Number | K152176 |
| Device Name: | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Contact | Joseph Ginete |
| Correspondent | Joseph Ginete 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 | 2015-08-04 |
| Decision Date | 2015-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937107751 | K152176 | 000 |
| 00840937101605 | K152176 | 000 |
| 00840937101582 | K152176 | 000 |
| 00840937101568 | K152176 | 000 |