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Gds Technology, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K020138STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB COFebruary 11, 2002
K994073HEMOSITE TEST SYSTEMJanuary 14, 2000
K992132CHOLESITE TEST SYSTEMAugust 20, 1999
K973649HEMOSITE TEST SYSTEMAugust 31, 1998
K971145GLUCOSITE TEST SYSTEMSeptember 17, 1997
K911801KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CONJuly 1, 1991
K882038GDS ENZYMATIC SALICYLATE REAGENTJune 24, 1988
K880829GDS ENZYMATIC ACETAMINOPHEN REAGENTMay 27, 1988