CHEMATICS, INC.

FDA Device Registration & Listing · NORTH WEBSTER, IN, US · Registration 1825396

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
1825396
FEI Number
1825396
Entity Name
CHEMATICS, INC.
City/State/Country
NORTH WEBSTER, IN, US
Establishment Address
HWY. 13 SOUTH, NORTH WEBSTER, IN 46555, US
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
CHEMATICS, INC. (Owner Number: 1825396)
Owner / Operator Contact Address
PO BOX 293, 4519 STATE RD. 13 SOUTH, North Webster, IN 46555, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K864159
PMA Number
N/A

All Registered Proprietary Names

Chemcard Cholesterol Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2007-12-31

Official Correspondent

Ellesha Hughes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CHEMATICS, 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
K790947 Macomb Chemical Co. AUTO ENZYMATIC CHOLESTEROL 1979-06-28
K885023 Em Diagnostic Systems, Inc. CHOLESTEROL TEST ITEM NUMBER: SR1011 1989-02-17
K771508 Instrumentation Laboratory CO MULTISTAT III CHOLESTEROL TEST 1977-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1825396. Last updated year: 2026. Please use registration number 1825396 when referencing this establishment in official correspondence.
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