510(k) K040887

Device: B-R-A-H-M-S PCT LIA
Applicant: BRAHMS AKTIENGESELLSCHAFT
510(k) number: K040887
Product code: NTM
Decision: Substantially Equivalent (SESE)
Decision date: 2005-01-07
Date received: 2004-04-05
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: MELISSA MAHALL
Address: 11800 Baltimore Ave. Suite 105 Beltsville MD US 20705 20705

FDA Registration Numbers#

3005174594
3003561301
9610240
8020790
2020726
3005847079
9610126
1219913
3002895169

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
K071146	VIDAS B.R.A.H.M.S. PCT ASSAY	bioMerieux, Inc.	2007-10-11

Legacy Summary#

summary

FDA Review#

Decision Summary