ISOAMP HSV ASSAY


Device Classification Name

herpes simplex virus nucleic acid amplification assay

510(k) Number K111951
Device Name ISOAMP HSV ASSAY
Applicant
BIOHELIX CORPORATION
32 tozer rd
beverly, 
MA 
01915

Applicant Contact fran white
Correspondent
BIOHELIX CORPORATION
32 tozer rd
beverly, 
MA 
01915

Correspodent Contact fran white
Regulation Number 866.3305
Classification Product Code
OQO  
Date Received 07/08/2011
Decision Date 09/27/2011
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