Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1029182

FEI Number

1029182

Entity Name

CAMBRIDGE DIAGNOSTIC PRODUCTS, INC.

City/State/Country

Fort Lauderdale, FL, US

Establishment Address

6880 NW 17TH AVE, Fort Lauderdale, FL 33309, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CAMBRIDGE DIAGNOSTIC PRODUCTS, INC. (Owner Number: 1029182)

Owner / Operator Contact Address

6880 N.W. 17TH AVE., --, Fort Lauderdale, FL 33309, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CAMCO STAIN PAK CAMCO PLATECOUNT CAMCO QUIK STAIN II CAMCO QUIK STAIN CAMCO WRIGHT STAIN CAMCO POLY-TET STAIN CAMCO WRIGHT STAIN BUFFER pH 6.8 SEQUESTER-SOL CAMCO WRIGHT STAIN BUFFER pH 7.15 CAMCO STAIN PAK FIXATIVE SOLUTION CAMCO FIXATIVE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQC	Stains, Hematology	Hematology	Class 1	864.1850	1992-08-27
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1992-08-27
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	1992-08-27

Official Correspondent

ROY GOLD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CAMBRIDGE DIAGNOSTIC PRODUCTS, 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
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03
K761138	Zeus Scientific, Inc.	FA TISSUE FIXATIVE & WASH SET	1978-01-06
K842913	E K Ind., Inc.	WRIGHT STAIN FIXATIVE	1984-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2012	EMD Chemicals Inc.	1	Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

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3007496191	Cancer Diagnostics, Inc.	Durham, NC, US
3017970519	CHAPTEC AMERICA	Montreal Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1029182. Last updated year: 2026. Please use registration number 1029182 when referencing this establishment in official correspondence.