Ams Diagnostics

FDA Filings

This page includes the latest FDA filings for Ams Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009128555
• FEI Number: 3009128555
• Name: AMS DIAGNOSTICS
• Owner & Operator: AMS Diagnostics
• Contact Address: 1790 North Commerce Parkway ; Weston FL 33326 US
• Official Correspondent:
  • Samuel Burgos
  • x-954-2170040-302
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1790 N Commerce Pkwy ; Weston, FL 33326 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K172232 AMS Diagnostics	LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine Reagent, LIASYS 600	2019-06-12
PMN K080468 | JJE AMS DIAGNOSTICS	Liasys 330	2017-04-28
PMN K080468 | JGS AMS DIAGNOSTICS	Liasys 330	2017-04-28
PMN K080468 | CIT AMS DIAGNOSTICS	Liasys 330	2017-04-28
PMN K080468 | CGZ AMS DIAGNOSTICS	Liasys 330	2017-04-28
PMN K080468 | CGX AMS DIAGNOSTICS	Liasys 330	2017-04-28
PMN K080468 | CFR AMS DIAGNOSTICS	Liasys 330	2017-04-28
PMN K080468 | CEM AMS DIAGNOSTICS	Liasys 330	2017-04-28
PMN K080468 | CDN AMS DIAGNOSTICS	Liasys 330	2017-04-28
PMN K941287 | CKA AMS DIAGNOSTICS	ALT/SGPT	2016-04-05
PMN K914873 | CIG AMS DIAGNOSTICS	Bilirubin D.	2016-04-05
PMN K853592 | JGJ AMS DIAGNOSTICS	Magnesium	2016-04-05
PMN K832870 | CIG AMS DIAGNOSTICS	Bilirubin T.	2016-04-05
PMN K822471 | CIX AMS DIAGNOSTICS	Albumin	2016-04-05
PMN K822470 | CEO AMS DIAGNOSTICS	Inorganic Phosphorus	2016-04-05
PMN K113131 | JJE AMS DIAGNOSTICS	LIASYS 450	2016-04-05
PMN K113131 | JJE AMS DIAGNOSTICS	LIASYS 450 GLUCOSE & ISE (Na,K,Cl)	2016-04-05
PMN K113131 | JGS AMS DIAGNOSTICS	LIASYS 450	2016-04-05
PMN K113131 | JGS AMS DIAGNOSTICS	LIASYS 450 GLUCOSE & ISE (Na,K,Cl)	2016-04-05
PMN K113131 | CGZ AMS DIAGNOSTICS	LIASYS 450	2016-04-05
PMN K113131 | CGZ AMS DIAGNOSTICS	LIASYS 450 GLUCOSE & ISE (Na,K,Cl)	2016-04-05
PMN K113131 | CFR AMS DIAGNOSTICS	LIASYS 450	2016-04-05
PMN K113131 | CFR AMS DIAGNOSTICS	LIASYS 450 GLUCOSE & ISE (Na,K,Cl)	2016-04-05
PMN K113131 | CEM AMS DIAGNOSTICS	LIASYS 450	2016-04-05
PMN K113131 | CEM AMS DIAGNOSTICS	LIASYS 450 GLUCOSE & ISE (Na,K,Cl)	2016-04-05
PMN K993590 | LCP AMS DIAGNOSTICS	Fructosamine	2015-11-10
PMN K993590 | JJX AMS DIAGNOSTICS	Fructosamine	2015-11-10
PMN K993437 | CZW AMS DIAGNOSTICS	Complement C3	2015-11-10
PMN K993323 | CFF AMS DIAGNOSTICS	Immunoglobulin M	2015-11-10
PMN K993281 | DEW AMS DIAGNOSTICS	Immunoglobulin G	2015-11-10
PMN K993213 | CFF AMS DIAGNOSTICS	Immunoglobulin A	2015-11-10
PMN K961588 | JIY AMS DIAGNOSTICS	Microprotein	2015-11-10
PMN K812794 | CET AMS DIAGNOSTICS	Lipase	2015-11-10
PMN K073488 | MSJ AMS DIAGNOSTICS	Apolipoprotein B	2015-11-10
PMN K073488 | JJX AMS DIAGNOSTICS	Apolipoprotein B	2015-11-10
PMN K073488 | JIT AMS DIAGNOSTICS	Apolipoprotein B	2015-11-10
PMN K062105 | JJX AMS DIAGNOSTICS	Creatinine Enzymatic	2015-11-10
PMN K062105 | JFY AMS DIAGNOSTICS	Creatinine Enzymatic	2015-11-10
PMN K002651 | JIS AMS DIAGNOSTICS	C-Reactive Protein HS	2015-11-10
PMN K002651 | DCK AMS DIAGNOSTICS	C-Reactive Protein HS	2015-11-10
PMN K131556 | JJX AMS DIAGNOSTICS	Calibrators/Controls	2015-11-09
PMN K131556 | JIT AMS DIAGNOSTICS	Calibrators/Controls	2015-11-09
PMN K031539 | LCP AMS DIAGNOSTICS	Hemoglobin A1c	2015-11-09
PMN K120763 | LAS AMS DIAGNOSTICS	Oxycodone Homogenous Enzyme Immunoassay	2014-06-06
PMN K120763 | DLJ AMS DIAGNOSTICS	Oxycodone Homogenous Enzyme Immunoassay	2014-06-06
PMN K120763 | DJG AMS DIAGNOSTICS	Oxycodone Homogenous Enzyme Immunoassay	2014-06-06
PMN K120761 | LAS AMS DIAGNOSTICS	Opiates 2000 Enzyme Immunoassay	2014-06-06
PMN K120761 | DLJ AMS DIAGNOSTICS	Opiates 2000 Enzyme Immunoassay	2014-06-06
PMN K120761 | DJG AMS DIAGNOSTICS	Opiates 2000 Enzyme Immunoassay	2014-06-06
PMN K113661 | LAS AMS DIAGNOSTICS	Methamphetamine Enzyme Immunoassay	2014-06-06
PMN K113661 | LAF AMS DIAGNOSTICS	Methamphetamine Enzyme Immunoassay	2014-06-06
PMN K113661 | DLJ AMS DIAGNOSTICS	Methamphetamine Enzyme Immunoassay	2014-06-06
PMN K113139 | LAS AMS DIAGNOSTICS	Cocaine Metabolite Enzyme	2014-06-06
PMN K113139 | DLJ AMS DIAGNOSTICS	Cocaine Metabolite Enzyme	2014-06-06
PMN K113139 | DIO AMS DIAGNOSTICS	Cocaine Metabolite Enzyme	2014-06-06
PMN K110298 | DJG AMS DIAGNOSTICS	Opiates Enzyme Immunoassay	2014-06-06
PMN K110239 | LDJ AMS DIAGNOSTICS	Cannabinoids Homogenous Enzyme Immunoassay	2014-06-06
PMN K110239 | LAS AMS DIAGNOSTICS	Cannabinoids Homogenous Enzyme Immunoassay	2014-06-06
PMN K110239 | DLJ AMS DIAGNOSTICS	Cannabinoids Homogenous Enzyme Immunoassay	2014-06-06
PMN K102210 | LAS AMS DIAGNOSTICS	Amphetamines 500	2014-06-06
PMN K102210 | DLJ AMS DIAGNOSTICS	Amphetamines 500	2014-06-06
PMN K102210 | DKZ AMS DIAGNOSTICS	Amphetamines 500	2014-06-06
PMN K101195 | LAS AMS DIAGNOSTICS	6-Acetylmorphine Enzyme Immunoassay	2014-06-06
PMN K101195 | DLJ AMS DIAGNOSTICS	6-Acetylmorphine Enzyme Immunoassay	2014-06-06
PMN K101195 | DJG AMS DIAGNOSTICS	6-Acetylmorphine Enzyme Immunoassay	2014-06-06
PMN K090844 | LAS AMS DIAGNOSTICS	Buprenorphine Enzyme Immunoassay	2014-06-06
PMN K090844 | DLJ AMS DIAGNOSTICS	Buprenorphine Enzyme Immunoassay	2014-06-06
PMN K090844 | DJG AMS DIAGNOSTICS	Buprenorphine Enzyme Immunoassay	2014-06-06
PMN K051088 | DKB AMS DIAGNOSTICS	Multi Analyte Urine Drugs of Abuse Calibrator	2014-06-06
PMN K051088 | DIF AMS DIAGNOSTICS	Multi Analyte Urine Drugs of Abuse Calibrator	2014-06-06
PMN K050733 | LAS AMS DIAGNOSTICS	Oxycodone Enzyme Immunoassay	2014-06-06
PMN K050733 | DLJ AMS DIAGNOSTICS	Oxycodone Enzyme Immunoassay	2014-06-06
PMN K050733 | DJG AMS DIAGNOSTICS	Oxycodone Enzyme Immunoassay	2014-06-06
PMN K033885 | JXN AMS DIAGNOSTICS	Bmbp Enzyme Immunoassay	2014-06-06
PMN K033885 | JXM AMS DIAGNOSTICS	Bmbp Enzyme Immunoassay	2014-06-06
PMN K033885 | DJR AMS DIAGNOSTICS	Bmbp Enzyme Immunoassay	2014-06-06
PMN K033885 | DIS AMS DIAGNOSTICS	Bmbp Enzyme Immunoassay	2014-06-06
PMN K033866 | LCM AMS DIAGNOSTICS	Camp (cocaine) Multiple Analyte Immunoassay	2014-06-06
PMN K033866 | DZK AMS DIAGNOSTICS	Camp (cocaine) Multiple Analyte Immunoassay	2014-06-06
PMN K033866 | DJG AMS DIAGNOSTICS	Camp (cocaine) Multiple Analyte Immunoassay	2014-06-06
PMN K033866 | DIO AMS DIAGNOSTICS	Camp (cocaine) Multiple Analyte Immunoassay	2014-06-06
PMN K033094 | LAS AMS DIAGNOSTICS	Ecstasy	2014-06-06
PMN K033094 | DLJ AMS DIAGNOSTICS	Ecstasy	2014-06-06
PMN K033094 | DKZ AMS DIAGNOSTICS	Ecstasy	2014-06-06
PMN K032764 | LAS AMS DIAGNOSTICS	Barbiturate Enzyme Immunoassay	2014-06-06
PMN K032764 | DLJ AMS DIAGNOSTICS	Barbiturate Enzyme Immunoassay	2014-06-06
PMN K032764 | DIS AMS DIAGNOSTICS	Barbiturate Enzyme Immunoassay	2014-06-06
PMN K032461 | DNN AMS DIAGNOSTICS	Ethyl Alcohol Enzymatic Assay	2014-06-06
PMN K032461 | DKC AMS DIAGNOSTICS	Ethyl Alcohol Enzymatic Assay	2014-06-06
PMN K032461 | DIC AMS DIAGNOSTICS	Ethyl Alcohol Enzymatic Assay	2014-06-06
PMN K032365 | LAS AMS DIAGNOSTICS	Benzodiazepine Enzyme Immunoassay	2014-06-06
PMN K032365 | JXM AMS DIAGNOSTICS	Benzodiazepine Enzyme Immunoassay	2014-06-06
PMN K032365 | DLJ AMS DIAGNOSTICS	Benzodiazepine Enzyme Immunoassay	2014-06-06
PMN K031797 | DLJ AMS DIAGNOSTICS	Methadone Metabolite	2014-06-06
PMN K031797 | DJR AMS DIAGNOSTICS	Methadone Metabolite	2014-06-06
PMN K023795 | JXN AMS DIAGNOSTICS	Propoxyphene Enzyme Immunoassay	2014-06-06
PMN K023317 | DJR AMS DIAGNOSTICS	Methadone Enzyme Immunoassay	2014-06-06
PMN K023316 | LAS AMS DIAGNOSTICS	Single Analyte Urine Drugs of Abuse Calibrator	2014-06-06
PMN K023316 | DLJ AMS DIAGNOSTICS	Single Analyte Urine Drugs of Abuse Calibrator	2014-06-06
PMN K021887 | LDJ AMS DIAGNOSTICS	Cannabinoids Enzyme Immunoassay	2014-06-06
PMN K021449 | DLJ AMS DIAGNOSTICS	Cannabinoids DoA Calibrators	2014-06-06
PMN K941315 | JQB AMS DIAGNOSTICS	GGT	2013-08-02
PMN K941313 | CJE AMS DIAGNOSTICS	Alkaline Phosphatase	2013-08-02
PMN K921625 | CIC AMS DIAGNOSTICS	Calcium	2013-08-02
PMN K072523 | LBR AMS DIAGNOSTICS	LDL	2013-08-02
PMN K072523 | JJX AMS DIAGNOSTICS	LDL	2013-08-02
PMN K023396 | CIJ AMS DIAGNOSTICS	AMYLASE	2013-08-02