Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007145015

FEI Number

3007145015

Entity Name

Revvity Health Sciences, Inc.

City/State/Country

Greenville, SC, US

Establishment Address

17 P&N Drive, Greenville, SC 29611, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

K121864

PMA Number

N/A

All Registered Proprietary Names

Contract Manufactured Collection Device with Ahlstrom 226 filter paper. Revvity 226 Sample Collection Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJC	Newborn Screening Specimen Collection Paper	Clinical Chemistry	Class 2	862.1675	2013-03-14

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
3009981484	Revvity Health Sciences, Inc.	Hopkinton, MA, US
8043909	WALLAC OY	TURKU Varsinais-Suomi, FI

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Similar Registrations

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3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT
3042364673	NEURALYTIX LLC	Fruita, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007145015. Last updated year: 2026. Please use registration number 3007145015 when referencing this establishment in official correspondence.