Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015222335

FEI Number

3015222335

Entity Name

PEROSPHERE TECHNOLOGIES INC.

City/State/Country

Danbury, CT, US

Establishment Address

108 Mill Plain Road, Suite 301, Danbury, CT 06811, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Perosphere Technologies Inc. (Owner Number: 10079359)

Owner / Operator Contact Address

108 Mill Plain Road, Suite 301, Danbury, CT 06811, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Perosphere ClotChek

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2020-12-02

Official Correspondent

Daryl Mootoo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Perosphere Technologies 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
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05	bioMerieux	2	The MDA system with MDA Antithrombin III MDA Heparin
Z-0736-04	Instrumentation Laboratory Co.	2	ACL Futura Instrument Analyzer
Z-0737-04	Instrumentation Laboratory Co.	2	ACL Advance Instrument Analyzer

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015222335. Last updated year: 2026. Please use registration number 3015222335 when referencing this establishment in official correspondence.