AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI


Device Classification Name

antigens, nontreponemal, all

510(k) Number K992124
Device Name AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI
Applicant
AVANTI POLAR LIPIDS, INC.
700 industrial park dr.
alabaster, 
AL 
35007 -9105

Applicant Contact rowena shaw
Correspondent
AVANTI POLAR LIPIDS, INC.
700 industrial park dr.
alabaster, 
AL 
35007 -9105

Correspodent Contact rowena shaw
Regulation Number 866.3820
Classification Product Code
GMQ  
Date Received 06/23/1999
Decision Date 09/20/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No