The following data is part of a premarket notification filed by Coretests, Inc with the FDA for Accu News Drug Screening Test Card/urine Cup.
| Device ID | K152590 |
| 510k Number | K152590 |
| Device Name: | ACCU NEWS Drug Screening Test Card/Urine Cup |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | CORETESTS, INC 6190 YARROW DRIVE Carlsbad, CA 92011 |
| Contact | Eric Sun |
| Correspondent | Eric Sun CORETESTS, INC 6190 YARROW DRIVE Carlsbad, CA 92011 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-10 |
| Decision Date | 2016-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850042559021 | K152590 | 000 |