The following data is part of a premarket notification filed by Technical Resources, Inc. with the FDA for Drug Abuse Dipsticks.
Device ID | K790805 |
510k Number | K790805 |
Device Name: | DRUG ABUSE DIPSTICKS |
Classification | Thin Layer Chromatography, Amphetamine |
Applicant | TECHNICAL RESOURCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DIT |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-25 |
Decision Date | 1979-06-06 |