AERSCHER DIAGNOSTICS

FDA Device Registration & Listing · CHESTERTOWN, MD, US · Registration 1123776

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
1123776
FEI Number
1000219815
Entity Name
AERSCHER DIAGNOSTICS
City/State/Country
CHESTERTOWN, MD, US
Establishment Address
125 Dixon Drive, CHESTERTOWN, MD 21620, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AERSCHER DIAGNOSTICS (Owner Number: 9007799)
Owner / Operator Contact Address
125 Dixon Drive, --, Chestertown, MD 21620, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K905782
PMA Number
N/A

All Registered Proprietary Names

HemaPrompt

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2008-01-02
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2008-01-02

Official Correspondent

ROBERT SCHREIBER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AERSCHER DIAGNOSTICS
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
K162333 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step Fecal Occult Blood (FOB) Test 2017-05-14

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1123776. Last updated year: 2026. Please use registration number 1123776 when referencing this establishment in official correspondence.
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