Perkinelmer Health Sciences Inc

FDA Filings

This page includes the latest FDA filings for Perkinelmer Health Sciences Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007145015
• FEI Number: 3007145015
• Name: PerkinElmer Health Sciences Inc.
• Owner & Operator: PERKINELMER, INC.
• Contact Address: 940 Winter Street ; Waltham MA 02451 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 17 P&N Drive ; Greenville, SC 29611 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3006159931
• FEI Number: 3006159931
• Name: PERKINELMER Health Sciences, Inc.
• Owner & Operator: PERKINELMER, INC.
• Contact Address: 940 Winter Street ; Waltham MA 02451 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 940 WINTER STREET ; North Waltham, MA 02451 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3004189868
• FEI Number: 3004189868
• Name: PerkinElmer Health Sciences, INC.
• Owner & Operator: PerkinElmer Health Sciences, Inc
• Contact Address: 23595 CABOT BLVD #106 ; Hayward CA 94545 US
• Official Correspondent:
  • Shawn You
  • x-650-8721800-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 23595 Cabot BLVD Suite 106; Hayward, CA 94545 US
• Establishment Type: Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PMN BK100008 | OQX PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	ABORh Card	2020-03-05
KLI PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	Total Thyroxine (T4) Emzyme Immunoassays	2019-12-03
JLS PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	Progesterone Emzyme Immunoassays	2019-12-03
JKD PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	C-Peptides of Proinsulin (C-Pep) Emzyme Immunoassays	2019-12-03
CHP PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	Insulin Emzyme Immunoassays	2019-12-03
CHP PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	Estradiol Emzyme Immunoassays	2019-12-03
CGJ PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	Follicle Stimulating Hormone (FSH) Emzyme Immunoassays	2019-12-03
CFT PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	Prolactin Emzyme Immunoassays	2019-12-03
CFP PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	Insulin Emzyme Immunoassays	2019-12-03
CFL PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	Human Growth Hormone (HGH) Emzyme Immunoassays	2019-12-03
CEP PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	LH Emzyme Immunoassays	2019-12-03
CDP PerkinElmer Health Sciences, INC. [PerkinElmer Health Sciences, Inc]	Total Triiodothyronine (T3) Emzyme Immunoassays	2019-12-03
NNK PerkinElmer Health Sciences Inc. [PERKINELMER, INC.]	PerkinElmer GRNK2	2019-02-21
NNK PerkinElmer Health Sciences Inc. [PERKINELMER, INC.]	PerkinElmer GRNK1	2019-02-21
PMN K173568 | NQL PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoBase 2 Succinylacetone Assay Solution (3046-0010)	2018-09-12
PMN K173568 | NQL PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoBase 2 Non-derivatized MSMS kit (3044-001U)	2018-09-12
PMN K173568 | NQL PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoBase 2 Non-derivatized Assay Solutions (3045-0010)	2018-09-12
PMN K173829 | QCM PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoLSD MSMS kit (3093-001U)	2018-07-24
PMN K173829 | QCL PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoLSD MSMS kit (3093-001U)	2018-07-24
PMN K173829 | PQW PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoLSD MSMS kit (3093-001U)	2018-07-24
PMN K173829 | PQV PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoLSD MSMS kit (3093-001U)	2018-07-24
PMN K173829 | PQU PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoLSD MSMS kit (3093-001U)	2018-07-24
PMN K173829 | PQT PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoLSD MSMS kit (3093-001U)	2018-07-24
PMN K121864 | PJC PerkinElmer Health Sciences Inc. [PERKINELMER, INC.]	PerkinElmer 226 Sample Collection Device	2013-03-14
PMN K121864 | PJC PerkinElmer Health Sciences Inc. [PERKINELMER, INC.]	Contract Manufactured Collection Device with Ahlstrom 226 filter paper.	2013-03-14
PMN K083130 | NQL PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoBase Succinylacetone Assay Solution (3042-0010)	2009-07-13
PMN K083130 | NQL PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoBase Non-Derivatized MSMS Kit (3040-001U)	2009-07-13
PMN K083130 | NQL PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoBase Non-Derivatized Assay Solutions (3041-0010)	2009-07-13
PMN DEN040002 | NQL PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoGram Derivatized Solutions (3030-0010)	2007-02-20
PMN DEN040002 | NQL PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]	NeoGram Amino Acids and Acylcarnitines, Tandem Mass Spectrometry kit (3026-0030)	2007-02-20

Similar & Related FDA Registered Companies

• Perkinelmer Health Sciences Canada, Inc

Related Finance Registrations

NCAGE Code	1LNR8	PERKINELMER HEALTH SCIENCES, INC
NCAGE Code	1MCW2	PERKINELMER HEALTH SCIENCES, INC
CAGE Code	1LNR8	PERKINELMER HEALTH SCIENCES, INC
CAGE Code	1MCW2	PERKINELMER HEALTH SCIENCES, INC
S.A.M. Registration	1MCW2 [132010856]	PERKINELMER HEALTH SCIENCES, INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091733343	Rotterdam,Netherlands -> New York, New York	CHEMICALS LOADED ONTO 20 PALLETS HS CODES 3 822 UN 1170 ETHANOL SOLUTION CLASS 3 PG III II	400 PCS
2020091740658	Rotterdam,Netherlands -> New York, New York	CHEMICALS LOADED ONTO 20 PALLETS HS CODES 382 2 UN 1170 ETHANOL SOLUTION CLASS 3 PG III II	400 PCS
2020090326537	Rotterdam,Netherlands -> New York, New York	CHEMICALS LOADED ONTO 12 PALLETS UN1993 FLAM MABLE LIQUID N.O.S. 124TRIMETHYLBENZENE CLASS 3 PG III UN2734 AMINES LIQUID CORROSIVE FLAM MABLE N.O.S. 3METHOXYPROPYLAMINE CLASS 8 3 PG I HS CODES 292250 382200 392330 391990	475 PKG
2020082062897	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	CHEMICALS LOADED ONTO 12 PALLETS UN1993 FLAM MABLE LIQUID N.O.S. 124TRIMETHYLBENZENE CLASS 3 PG III UN2734 AMINES LIQUID CORROSIVE FLAM MABLE N.O.S. 3METHOXYPROPYLAMINE CLASS 8 3 PG I HS CODES 292250 382200 392330 391990	475 PKG
2020052224220	Shanghai ,China (Mainland) -> Oakland, California	PLASTIC BOTTLE/ ALUMINUM FOIL BAG/ PACKED DES ICCANT	90 PKG
2020020419118	Shanghai ,China (Mainland) -> Oakland, California	GLASS BOTTLE RUBBER STOPPER	69 PKG
2019110819375	Shanghai ,China (Mainland) -> Oakland, California	PACKING BOX	75 PKG
2019101718850	Shanghai ,China (Mainland) -> Oakland, California	PLASTIC BOTTLE SPONGE LINING	88 PKG