AUER PRECISION

FDA Device Registration & Listing · Mesa, AZ, US · Registration 2030652

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
2030652
FEI Number
3000205059
Entity Name
AUER PRECISION
City/State/Country
Mesa, AZ, US
Establishment Address
1050 W. Birchwood Ave, Mesa, AZ 85210, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Auer Precision (Owner Number: 10056705)
Owner / Operator Contact Address
1050 W. Birchwood Ave, Mesa, AZ 85210, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Alinity h-series Slide Label Cartridge Alinity h-series Smear Tape Cartridge eQUANT System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2018-01-08
QZX Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing Microbiology Class 2 866.1650 2025-12-08
JTN Susceptibility Test Discs, Antimicrobial Microbiology Class 2 866.1620 2025-12-08

Official Correspondent

Sharon Higgins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3020440077 AUER 2260 Mesa, AZ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K002664 Hardy Diagnostics HARDYDISK LEVOFLOXACIN, 5MCG 2000-10-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030652. Last updated year: 2026. Please use registration number 2030652 when referencing this establishment in official correspondence.
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