Simmler, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K895745SICKLE CELL SOLUBILITY TEST KITNovember 29, 1989
K874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)February 11, 1988
K874595MULTICHEM (R) MAGNESIUM REAGENTJanuary 21, 1988
K874820MULTICHEM HDL PRECIPITATING REAGENT #S0914January 7, 1988
K874812MULTICHEM CHLORIDE REAGENT S0933December 18, 1987
K874311MULTICHEM (R) TOTAL BILIRUBINNovember 25, 1987
K874049MULTICHEM ALBUMIN REAGENT S0902October 29, 1987
K874038MULTICHEM INORGANIC PHOSPHOROUS S0923October 28, 1987
K873725MULTICHEM CREATININE REAGENT S0917October 20, 1987
K873761MULTICHEM ALKALINE PHOSPHATASE (S0903)October 7, 1987
K873697MULTICHEM CALCIUM S0910October 2, 1987
K872010MULTICHEM LDH-L REAGENTJune 11, 1987
K871976MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919June 5, 1987
K871975MULTICHEM TOTAL PROTEIN REAGENT #S0928June 5, 1987
K853244TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZEAugust 12, 1985
K853049ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZEAugust 2, 1985
K853050CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZAugust 2, 1985
K843938LINEAR ENZYMATIC URIC ACID SYSTEMOctober 30, 1984
K831700MULTICHEM ENZYMATIC CHOLESTEROL SYSJuly 19, 1983
K831398LINEAR ENZMATIC URIC ACID SYSTEMJune 8, 1983