510(k) K071146

Device: VIDAS B.R.A.H.M.S. PCT ASSAY
Applicant: BIOMERIEUX, INC.
510(k) number: K071146
Product code: NTM
Decision: Substantially Equivalent (SESE)
Decision date: 2007-10-11
Date received: 2007-04-24
Regulation: 866.3210
Classification name: Antigen, Inflammatory Response Marker, Sepsis
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: NIKITA S MAPP
Address: 595 Anglum Rd. Hazelwood MO US 63042 63042

FDA Registration Numbers#

9610240
1219913
9610126
3005847079
3002895169
2020726
3005174594
8020790
3003561301

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NTM #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K070310	B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM	Brahms Aktiengesellschaft	2008-03-31
K040887	B-R-A-H-M-S PCT LIA	Brahms Aktiengesellschaft	2005-01-07

Legacy Summary#

summary

FDA Review#

Decision Summary