GC OIA


Device Classification Name

antigen, enzyme linked immunoabsorbent assay, neisseria gonorrhoeae

510(k) Number K023947
Device Name GC OIA
Original Applicant
THERMO BIOSTAR, INC.
331 south 104th st.
louisville, 
CO 
80027

Original Contact john g adams
Regulation Number 866.3390
Classification Product Code
LIR  
Date Received 11/27/2002
Decision Date 04/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No