The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hycor Accupinch Morphine Test.
Device ID | K900173 |
510k Number | K900173 |
Device Name: | HYCOR ACCUPINCH MORPHINE TEST |
Classification | Enzyme Immunoassay, Opiates |
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 | DJG |
CFR Regulation Number | 862.3650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-12 |
Decision Date | 1990-03-30 |