Alpkem Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K894011TOTAL GALACTOSEJanuary 11, 1990
K891070PHENYLALANINE (NINHYDRIN REACTION)October 27, 1989
K890334TOTAL CHOLESTEROL REAGENTMay 3, 1989
K890337TRIGLYCERIDES - GPO REAGENTMarch 9, 1989
K890336GLUCOSE (GOD) REAGENTFebruary 27, 1989
K890333ALBUMIN REAGENTFebruary 17, 1989
K890332RFA/2 RAPID FLOW ANALYZER W/COMPUTERFebruary 17, 1989
K890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.February 17, 1989
K883020RFA-300 RAPID FLOW ANALYZER W/COMPUTERSeptember 2, 1988
K860367MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)April 11, 1986
K852005MG REAGENTJune 25, 1985
K852002CA BUFFER CA DYEJune 25, 1985
K851990INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLUJune 25, 1985
K852006TP BIURET REAGENTJune 10, 1985
K852001AMY REAGENTJune 10, 1985
K851999G-GT REAGENTJune 10, 1985
K851994AST ASPARTATE AMINOTRANSFERASE REAGENTJune 3, 1985
K851996LD-L REAGENTMay 31, 1985
K852003IP ACID REAGENT IP MOLY BDATE REAGENTMay 31, 1985
K852009T-CHO REAGENTMay 30, 1985