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Synermed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
45
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITSeptember 25, 1997
K972716SYNERMED TOTAL BILIRUBIN REAGENT KITAugust 7, 1997
K971491SYNERMED IR 200 CHEMISTRY ANALYZERJune 26, 1997
K962479SYNERMED ISE REAGENTSMarch 3, 1997
K963939SYNERMED DIRECT BILIRUBIN REAGENT KITDecember 18, 1996
K960793SYNERMED ENZYMATIC CO2 REAGENT KITMarch 11, 1996
K953395SYNERMED CALCIUM REAGENT KITAugust 31, 1995
K952179SYNERMED ISE REAGENTSJune 20, 1995
K943924CREATININE-PO REAGENT KITSeptember 20, 1994
K941091SYNERMED AMYLASE REAGENT KITMay 3, 1994
K935662SYNERMED IR 500 CHEMISTRY ANALYZERApril 26, 1994
K941400SYNERMED ISE REAGENTSApril 26, 1994
K940571SYNERMEDIR CAL I AND SYNERMED IR CAL IIApril 21, 1994
K940570SYNERMED TOTAL BILIRUBIN REAGENT KITApril 20, 1994
K940194SYNERMED ISE REAGENTSApril 5, 1994
K933026SYNERMED DIRECT BILIRUBIN REAGENT KITOctober 28, 1993
K931958SYNERMED GGT REAGENT KITSeptember 8, 1993
K931986AMP ALKALINE PHOSPHATASE REAGENT KITSeptember 8, 1993
K930932SYNERMED CREATINE KINASE REAGENT KITMay 11, 1993
K926511SYNERMED SINGLE REAGENT CREATININE KITFebruary 18, 1993