SPECTRA MRSA


Device Classification Name

culture media, antimicrobial susceptibility test, excluding mueller hinton agar

510(k) Number K073027
Device Name SPECTRA MRSA
Applicant
Thermo Fisher Scientific
12150 santa fe drive
lenexa, 
KS 
66215

Applicant Contact mary ann silvius
Correspondent
Thermo Fisher Scientific
12150 santa fe drive
lenexa, 
KS 
66215

Correspodent Contact mary ann silvius
Regulation Number 866.1700
Classification Product Code
JSO  
Date Received 10/26/2007
Decision Date 02/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No