Realtime Laboratories, Inc

FDA Device Registration & Listing · Carrollton, TX, US · Registration 3012683224

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
3012683224
FEI Number
3012683224
Entity Name
Realtime Laboratories, Inc
City/State/Country
Carrollton, TX, US
Establishment Address
4100 Fairway Dr Ste 600, Carrollton, TX 75010, 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 Collection Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2009-03-24

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
3004762162 US BIOTEK LABORATORIES Shoreline, WA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012683224. Last updated year: 2026. Please use registration number 3012683224 when referencing this establishment in official correspondence.
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