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510(k) K992124

AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI by Avanti Polar Lipids, Inc. — Product Code GMQ

K992124 is an FDA 510(k) premarket notification submitted by Avanti Polar Lipids, Inc. for the device "AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI". The FDA issued a decision of Substantially Equivalent on September 20, 1999. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1999
Date Received
June 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

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FDA data resources