CRACK-IT CHAP SCREEN

Thin Layer Chromatography, Cocaine

SAKERS, INC.

The following data is part of a premarket notification filed by Sakers, Inc. with the FDA for Crack-it Chap Screen.

Pre-market Notification Details

Device IDK874389
510k NumberK874389
Device Name:CRACK-IT CHAP SCREEN
ClassificationThin Layer Chromatography, Cocaine
Applicant SAKERS, INC. PLAZA 47 800 DELSEA DRIVE, SUITE 10 Westville,  NJ  08093
ContactAkers, Jr
CorrespondentAkers, Jr
SAKERS, INC. PLAZA 47 800 DELSEA DRIVE, SUITE 10 Westville,  NJ  08093
Product CodeDMN  
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-27
Decision Date1989-02-07

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