The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis Cthc Urine Calibrators, Immunalysis Cthc Urine Control Set.
| Device ID | K151203 |
| 510k Number | K151203 |
| Device Name: | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis CTHC Urine Calibrators, Immunalysis CTHC Urine Control Set |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | IMMUNALYSIS CORPORATION 829 TOWNE CENTER DR Pomona, CA 91767 |
| Contact | Joseph Ginete |
| Correspondent | Joseph Ginete IMMUNALYSIS CORPORATION 829 TOWNE CENTER DR Pomona, CA 91767 |
| Product Code | LDJ |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-05 |
| Decision Date | 2015-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937101292 | K151203 | 000 |
| 00840937101278 | K151203 | 000 |
| 00840937101254 | K151203 | 000 |
| 00840937101230 | K151203 | 000 |