510(k) K070310
- Device
- B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
- Applicant
- BRAHMS AKTIENGESELLSCHAFT
- 510(k) number
- K070310
- Product code
- NTM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-31
- Date received
- 2007-02-01
- 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
- JONAS LEICHTNER
- Address
- 2568a Riva Rd. Suite 207 Annapolis MD US 21401 21401
FDA Registration Numbers#
- 3005174594
- 3003561301
- 9610240
- 8020790
- 2020726
- 3005847079
- 9610126
- 1219913
- 3002895169
Source Documents#
Other 510(k) Records For Product Code NTM #
Legacy Summary#
summary
FDA Review#
Decision Summary