The following data is part of a premarket notification filed by Technam, Inc. with the FDA for Hi-m-test Morphine.
Device ID | K791551 |
510k Number | K791551 |
Device Name: | HI-M-TEST MORPHINE |
Classification | Hemagglutination Inhibition, Morphine |
Applicant | TECHNAM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DLR |
CFR Regulation Number | 862.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-14 |
Decision Date | 1979-10-17 |