510(k) K020610

Device: LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
Applicant: BIO-RAD
510(k) number: K020610
Product code: DIE
Decision: Substantially Equivalent (SESE)
Decision date: 2002-04-22
Date received: 2002-02-25
Regulation: 862.3280
Classification name: Heavy Metals Control Materials
Medical specialty: Toxicology
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Yvette Lloyd
Address: 9500 Jeronimo Rd. Irvine CA US 92618 92618

FDA Registration Numbers#

2016706
3010127294
3001431095

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00847661001843	Lyphochek	BIO-RAD LABORATORIES, INC.	2017-01-09
00847661001706	Lyphochek	BIO-RAD LABORATORIES, INC.	2017-01-09
00847661001690	Lyphochek	BIO-RAD LABORATORIES, INC.	2017-01-09
00847661001683	Lyphochek	BIO-RAD LABORATORIES, INC.	2017-01-09

Other 510(k) Records For Product Code DIE #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K990928	LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405	Bio-Rad	1999-04-16
K891691	LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II	Bio-Rad	1989-12-19
K890721	SHAPE-ACTIO METAL TOXICOLOGY CONTROL	Actio, Inc.	1989-04-10
K863915	SHAPE-ACTIO METAL TOXICOLOGY CONTROL	Shape Products Co.	1986-11-24

Legacy Summary#

summary

FDA Review#

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