Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1530126

FEI Number

1000515493

Entity Name

Remel Cleveland, A Division of Remel Inc.

City/State/Country

Oakwood Village, OH, US

Establishment Address

1 Thermo Fisher Way, Oakwood Village, OH 44146, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Thermo Fisher Scientific (Owner Number: 2517925)

Owner / Operator Contact Address

168 Third Avenue, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HPB1 Sensititre Haemophilus and Streptococcus pneumoniae MIC Plate T3470 Sensititre HTM Broth T3462-10 Sensititre Cation Adjusted Mueller- Hinton Broth w/TES V3030 Sensititre OptiRead Sensititre AIM Sensititre GN Panel Nephelometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2014-07-14
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2014-08-18
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2014-08-18
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2014-07-14
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2014-08-18
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2014-08-18
LIE	Reagent/Device, Inoculum Calibration	Microbiology	Class 2	866.1640	2014-08-18
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2014-08-18
LQM	Gram Negative Identification Panel	Microbiology	Class 1	866.2660	2011-12-19
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2014-07-14
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2014-07-14
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2014-07-14
JQX	Nephelometer, For Clinical Use	Clinical Chemistry	Class 1	862.2700	1998-09-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Thermo Fisher Scientific

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010455511	Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd	Suzhou Jiangsu, CN
3006190736	LABOMEX MBP	TIJUANA Baja California, MX
2517925	FISHER SCIENTIFIC COMPANY L.L.C.	PITTSBURGH, PA, US
3006440892	OXOID AUSTRALIA PTY LIMITED	THEBARTON South Australia, AU
1314344	Nalge Nunc International Corporation	Rochester, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K232967	bioMerieux, Inc.	VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)	2024-06-12
K944753	Radiometer America, Inc.	SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP	1995-02-24
K010508	Pasco Laboratories, Inc.	PASCO MIC AND MIC/ID PANELS	2001-04-23
K111394	Siemens Healthcare Diagnostics, Inc.	MICROSCAN MICROSTEP	2011-06-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2008	Thermo Fisher Scientific	1	Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.

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1950204	BIOMERIEUX, INC.	HAZELWOOD, MO, US
8021914	TREK DIAGNOSTIC SYSTEMS, LTD.	East Grinstead West Sussex, GB
3013718871	UPS Supply Chain Solutions, Inc.	Pedricktown, NJ, US
3031977134	bioMerieux, Inc.	Morrisville, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1530126. Last updated year: 2026. Please use registration number 1530126 when referencing this establishment in official correspondence.