Data / Medical devices / Jordan / Atlas Medical

Atlas Medical: FDA-registered device maker in Amman Al 'Asimah, Jordan, 2 510(k) clearances

Name: Atlas Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Atlas Medical is registered with the FDA (registration 3007126977) in Amman Al 'Asimah, Jordan. It lists 18 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 3, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007126977
Address: King Abdullah Industrial Estate, Sahab Free Zone Area P.O.Box 204, Amman Al 'Asimah, Jordan, 11512
Owner or operator: Atlas Medical (10026421)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: May 20, 2012
Registered through: 2026
Brand names listed: American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Amphetamines), American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Benzodiazepines), American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Buprenorphine), American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Cannabinoids (THC)), American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Cocaine metabolites), American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Methadone), American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Methamphetamines), American Screening Corp., PRECISION PLUS Multi-Drug Test Cup (Methylenedioxymethamphetamine (MDMA)) and more

Devices it lists

Device	Product code	Class	Role	Source
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Manufacturer	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Manufacturer	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Manufacturer	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Morphine	DNK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 3, 2019	K191099	Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel	DKZ	Substantially Equivalent	Atlas Medical	accessdata.fda.gov
August 3, 2011	K102760	ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001	LCX	Substantially Equivalent	Atlas Medical	accessdata.fda.gov

Compare with other makers

Updated October 3, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.