510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874389Substantially Equivalent

Crack-It Chap Screen

Sakers, Inc., Westville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874389 is the FDA 510(k) clearance record for CRACK-IT CHAP SCREEN, a class II device, cleared for Sakers, Inc. on under FDA product code DMN (Thin Layer Chromatography, Cocaine). FDA records list 2 510(k) clearances for Sakers, Inc., from to . As of , FDA records show no recalls naming K874389.

Clearance record

Decision date
Received
(469 days to decision)
Product code
DMN Thin Layer Chromatography, Cocaine
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Sakers, Inc. Plz. 47, Westville NJ
Third party review
No

Clearances, product code DMN

Trailing 12 months

FDA records hold no clearances under product code DMN in the trailing twelve months.

FDA records show no clearances under product code DMN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DMN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260