AMERITEKUSA, INC.

FDA Device Registration & Listing · EVERETT, WA, US · Registration 3025672

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3025672
FEI Number
1000126037
Entity Name
AMERITEKUSA, INC.
City/State/Country
EVERETT, WA, US
Establishment Address
125 130th St SE Ste 200, EVERETT, WA 98208, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AMERITEKUSA, INC. (Owner Number: 9002732)
Owner / Operator Contact Address
125 130 TH STREET SE, --, Everett, WA 98208, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K973957
PMA Number
N/A

All Registered Proprietary Names

dBest hCG 2 IU/ml Test Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-05-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMERITEKUSA, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964536 Teco Diagnostics ONE-STEP DIPSTICK PREGNANCY TEST 1997-02-11
K904016 Bhc Biotech , Ltd. MAXI TEST 1990-10-15
K870259 Leeco Diagnostics, Inc. VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 1987-03-10
K820822 Hybritech, Inc. TANDEM HCG KIT 1982-04-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-05 Abbott Health Products, Inc. 2
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

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2027969 Alere San Diego, Inc. San Diego, CA, US
1222302 American Laboratory Products Company Salem, NH, US
2032364 VICTORCH MEDITEK, INC. San Diego, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025672. Last updated year: 2026. Please use registration number 3025672 when referencing this establishment in official correspondence.
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