The following data is part of a premarket notification filed by Acro Biotech Llc. with the FDA for Acro Biotech Llc Rapid Opiates Urine Test; Catalog# Opi00100.
| Device ID | K053037 |
| 510k Number | K053037 |
| Device Name: | ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ACRO BIOTECH LLC. 9500 7TH STREET UNIT M Rancho Cucamonga, CA 91730 -9094 |
| Contact | Gregory Lee |
| Correspondent | Gregory Lee ACRO BIOTECH LLC. 9500 7TH STREET UNIT M Rancho Cucamonga, CA 91730 -9094 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-27 |
| Decision Date | 2006-06-15 |