Medical Device Manufacturer · US , Elkhart , IN

Gds Technology, LLC - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1988
7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Gds Technology, LLC Chemistry ✕

4 devices
1-4 of 4
Cleared Aug 20, 1999
CHOLESITE TEST SYSTEM
K992132 · CHH
Chemistry · 58d
Cleared Sep 17, 1997
GLUCOSITE TEST SYSTEM
K971145 · CGA
Chemistry · 173d
Cleared Jul 01, 1991
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
K911801 · JIN
Chemistry · 69d
Cleared Jun 24, 1988
GDS ENZYMATIC SALICYLATE REAGENT
K882038 · DKJ
Chemistry · 39d
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