THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST


the company

Device Classification Name

antigens, nontreponemal, all

510(k) Number K000687
Device Name THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
Original Applicant
BEACON BIOLOGICALS, INC.
6004 glendale dr.
boca raton, 
FL 
33433

Original Contact kanti daya
Regulation Number 866.3820
Classification Product Code
GMQ  
Date Received 02/29/2000
Decision Date 06/12/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Traditional
Reviewed by Third Party No

Combination Product

No