Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004049804

FEI Number

3004049804

Entity Name

Revvity Singapore Pte Ltd

City/State/Country

Singapore Central Singapore, SG

Establishment Address

438A Alexandra Road, 02-05/10, Alexandra Technopark, Singapore Central Singapore 119967, SG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Revvity, Inc. (Owner Number: 9912035)

Owner / Operator Contact Address

77 4th 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

Wizard2 Gamma Counter (Model 2470-0010, 2470-0020, 2470-0050, 2470-0100, 2470-0150, 2470-0200, 2480-0010)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJJ	Counter (Beta, Gamma) For Clinical Use	Clinical Chemistry	Class 1	862.2320	1993-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Castellanos Business: Revvity, Inc. Email: americas.regulatory@revvity.com Phone: (973) 5808347

Related Public Records

Same Entity

Revvity, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3032324401	Revvity Discovery Limited	Cambrige Cambridgeshire, GB
3007145015	Revvity Health Sciences, Inc.	Greenville, SC, US
3009981484	Revvity Health Sciences, Inc.	Hopkinton, MA, US
8043909	WALLAC OY	TURKU Varsinais-Suomi, FI

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872429	Iso-Data, Inc.	ISO-DATA 100 SERIES GAMMA COUNTER	1987-08-21

Similar Registrations

Registration Number	Establishment Name	Location
3003529145	DAXOR CORPORATION	Oak Ridge, TN, US
1219913	Siemens Healthcare Diagnostics Inc.	E Walpole, MA, US
1520597	CRESCENT MFG. CO.	FREMONT, OH, US
3044467533	TAROMED INC	Los Angeles, CA, US
3008775647	SHAKAM, LLC	Columbus, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004049804. Last updated year: 2026. Please use registration number 3004049804 when referencing this establishment in official correspondence.