The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hycor Accupinch Methamphetamine Test.
| Device ID | K904115 |
| 510k Number | K904115 |
| Device Name: | HYCOR ACCUPINCH METHAMPHETAMINE TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Ron Hoover |
| Correspondent | Ron Hoover HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1990-11-28 |