The following data is part of a premarket notification filed by Icl Scientific with the FDA for Hycor Sentry Drugs Of Abuse Urine Control.
| Device ID | K883942 |
| 510k Number | K883942 |
| Device Name: | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ICL SCIENTIFIC 11040 CONDOR AVE. Fountain Valley, CA 92708 |
| Contact | Ron Hoover |
| Correspondent | Ron Hoover ICL SCIENTIFIC 11040 CONDOR AVE. Fountain Valley, CA 92708 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-19 |
| Decision Date | 1988-11-10 |