HEMAGEN CRP 150 KIT (EIA METHOD)


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K960324
Device Name HEMAGEN CRP 150 KIT (EIA METHOD)
Applicant
HEMAGEN DIAGNOSTICS, INC.
34-40 bear hill rd.
waltlham, 
MA 
02154

Applicant Contact joseph m califano
Correspondent
HEMAGEN DIAGNOSTICS, INC.
34-40 bear hill rd.
waltlham, 
MA 
02154

Correspodent Contact joseph m califano
Regulation Number 866.5270
Classification Product Code
DCK  
Date Received 01/23/1996
Decision Date 03/12/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized