The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Eddp Specific Urine Enzyme Immunoassay, Immunalysis Eddp Urine Calibrators, Immunalysis Eddp Urine Control Sets.
| Device ID | K151395 |
| 510k Number | K151395 |
| Device Name: | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2015-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937111451 | K151395 | 000 |
| 00840937110997 | K151395 | 000 |
| 00840937107737 | K151395 | 000 |
| 00840937107720 | K151395 | 000 |
| 00840937107713 | K151395 | 000 |
| 00840937107706 | K151395 | 000 |