The following data is part of a premarket notification filed by Sakers, Inc. with the FDA for Crack-it Chap Screen.
Device ID | K874389 |
510k Number | K874389 |
Device Name: | CRACK-IT CHAP SCREEN |
Classification | Thin Layer Chromatography, Cocaine |
Applicant | SAKERS, INC. PLAZA 47 800 DELSEA DRIVE, SUITE 10 Westville, NJ 08093 |
Contact | Akers, Jr |
Correspondent | Akers, Jr SAKERS, INC. PLAZA 47 800 DELSEA DRIVE, SUITE 10 Westville, NJ 08093 |
Product Code | DMN |
CFR Regulation Number | 862.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-27 |
Decision Date | 1989-02-07 |