US BIOTEK LABORATORIES

FDA Device Registration & Listing · Shoreline, WA, US · Registration 3004762162

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
3004762162
FEI Number
3004762162
Entity Name
US BIOTEK LABORATORIES
City/State/Country
Shoreline, WA, US
Establishment Address
16020 Linden Ave N, Shoreline, WA 98133, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
US BioTek Laboratories (Owner Number: 10028954)
Owner / Operator Contact Address
16020 Linden Ave N, Shoreline, WA 98133, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Urine Transport Kit Urine Collection Kit Serum Collection Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OHZ Urine Transport Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2009-03-24
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2009-03-24
PQD Blood Specimen Collection Convenience Kit (Excludes Hiv) Clinical Chemistry Class 2 862.1675 2016-12-20

Official Correspondent

Seng Foong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

US BioTek 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
3012683224 Realtime Laboratories, Inc Carrollton, TX, US

Similar Registrations

Registration Number Establishment Name Location
3009888344 Isomedix Operations Inc El Paso, TX, US
9616088 Convertors de Mexico S. de R.L. de C.V CD.JUAREZ Chihuahua, MX
1061124 Sterigenics U.S., LLC Charlotte, NC, US
3013175547 PRINTCRAFT PRESS Idaho Falls, ID, US
3007075140 YELATMA INSTRUMENT-MAKING ENTERPRISE Ryazan Ryazanskaya Oblast', RU
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004762162. Last updated year: 2026. Please use registration number 3004762162 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.