Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032598

FEI Number

3003789989

Entity Name

Ameditech, Inc.

City/State/Country

San Diego, CA, US

Establishment Address

9940 Mesa Rim Rd, San Diego, CA 92121, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

eCUP + Drug Screening Device (REF 94615) - AMT Mfg eReader+ SEFRIA Amphetamine Oral Fluid Enzyme Immunoassay 100mL Kit eCUP + Drug Screening Device (REF 94615) SEFRIA Amphetamine Oral Fluid Enzyme Immunoassay 500mL Kit eCup+ Drug Screening Device (REF 94615) SEFRIA Benzoylecgonine Oral Fluid 100 mL Kit SEFRIA Benzoylecgonine Oral Fluid 500 mL Kit eCup+ Drug Screening Device (REF 94615) eCUP + Drug Screening Device eCUP + Drug Screening Device (REF 94615) - AMT Mfg Cannabinoid Oral Fluid HEIA 500 ml Cannabinoid Oral Fluid HEIA 100 ml SEFRIA Opiates Oral Fluid Enzyme Immunoassay 100 mL Kit SEFRIA Hydrocodone Oral Fluid eCup+ Drug Screening Device (REF 94615) SEFRIA Opiates Oral Fluid Enzyme Immunoassay 500 mL Kit SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 500mL Kit SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay Kit 100 mL Kit SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 100mL Kit SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay Kit 500 mL Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2020-03-03
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	1998-05-20
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2020-03-03
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3620	2020-03-03
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2020-03-03
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3150	2020-03-03
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2020-03-03
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2020-03-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

Similar Registrations

Registration Number	Establishment Name	Location
3007606081	WONDFO USA CO., LTD.	Bolingbrook, IL, US
3027519599	Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, CN
3032147516	ETERBIO, INC.	Zhuhai Guangdong, CN
3017060097	MLIFE DIAGNOSTICS LLC	Marshall, TX, US
3010934853	ADVIN BIOTECH, INC.	San Diego, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032598. Last updated year: 2026. Please use registration number 2032598 when referencing this establishment in official correspondence.