510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972618Substantially Equivalent

Quickscreen One Step Cocaine Screening Test (9070)

Phamatech Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972618 is the FDA 510(k) clearance record for QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070), a class II device, cleared for Phamatech on under FDA product code DMN (Thin Layer Chromatography, Cocaine). FDA records list 62 510(k) clearances for Phamatech, from to . As of , FDA records show no recalls naming K972618.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DMN Thin Layer Chromatography, Cocaine
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Phamatech 9520 Padgett St. #108-110, San Diego CA
510(k) summary
Summary
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