The following data is part of a premarket notification filed by Sakers, Inc. with the FDA for Crack-it Cannabinoid Screen.
Device ID | K874390 |
510k Number | K874390 |
Device Name: | CRACK-IT CANNABINOID SCREEN |
Classification | Enzyme Immunoassay, Cannabinoids |
Applicant | SAKERS, INC. 1001 LOWER LANDING RD. Blackwood, NJ 08012 |
Contact | Akers, Jr |
Correspondent | Akers, Jr SAKERS, INC. 1001 LOWER LANDING RD. Blackwood, NJ 08012 |
Product Code | LDJ |
CFR Regulation Number | 862.3870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-27 |
Decision Date | 1989-04-10 |