Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009981484

FEI Number

3009981484

Entity Name

Revvity Health Sciences, Inc.

City/State/Country

Hopkinton, MA, US

Establishment Address

68 Elm St, Hopkinton, MA 01748, US

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

JANUS G3 Automated Workstation (models CJL4G01, CJL4M01, CJL8001, CJL8G01, CJL8M01, CJLM001, CJLMG01, CJM4001) JANUS G3 NGS Express Workstation (model CJS4NGS) JANUS G3 Automated Workstation (models CJI4001, CJI4G01, CJI4M01, CJI8001, CJI8G01, CJI8M01, CJIM001, CJIMG01, CJL4001) JANUS G3 Automated Workstation (models CJM4G01, CJM4M01, CJM8001, CJM8002, CJM8G01, CJM8M01, CJMM001, CJMMG01, CJS4001) JANUS G3 Automated Workstation (models CJS8001, CJS8003, CJSM001, CJSM003, CJM8M03, CJL8M02, CJL8002) JANUS G3 Automated Workstation (CJM8003) Fontus Automated Liquid Handling Workstation (models CFL8H01, CFM8H01, CFL8L01, CFM8L01, CFL8H02, CFL8L02) Fontus Automated Liquid Handling Workstation (CFL8001, CFM8001)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	1993-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3004049804	Revvity Singapore Pte Ltd	Singapore Central Singapore, SG
3007145015	Revvity Health Sciences, Inc.	Greenville, SC, US
8043909	WALLAC OY	TURKU Varsinais-Suomi, FI

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

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3016068451	LABTURBO BIOTECH CORPORATION	Taipei, TW
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009981484. Last updated year: 2026. Please use registration number 3009981484 when referencing this establishment in official correspondence.