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Sandare Chemical Co., Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TESTSeptember 29, 1987
K862556SANDARE GLYCOHEMOGLOBIN PROCEDUREAugust 8, 1986
K860684SANDARE BCG ALBUMIN PROCEDUREMarch 17, 1986
K851395SANDARE IRON-BINDING CAPACITY PROCEDUREMay 7, 1985
K851394SANDARE IRON PROCEDUREApril 30, 1985
K844498SANDARE ALKALINE PHOSPHATASE PROCEDUREDecember 10, 1984
K842516SANDARE ACID PHOSPHATASE PROCEDUREAugust 17, 1984
K833898TRI-LEVEL BILIRUBIN CONTROLSJanuary 13, 1984
K832942TOTAL & DIRECT BILIRUBIN PROCEDURESNovember 7, 1983
K832632ALBUMIN PROCEDURE BCPSeptember 12, 1983
K832183SANDARE CALCIUM PROCEDUREAugust 24, 1983
K832169TOTAL PROTEIN PROCEDUREAugust 16, 1983
K812670SANDARE FAST 340 PHOSPHORUS PROCEDUREOctober 2, 1981
K812313SANDARE URIC ACID PROCEDURESeptember 1, 1981
K810514SANDARE NITROPRUSSIDE TEST PROCEDUREMarch 4, 1981
K802832SANDARE GLYCOHEMOGLOBIN PROCEDUREJanuary 16, 1981
K801422SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.July 8, 1980
K800780SANDARE LYOPHILIZED HEMOGLOBIN CONTROLSApril 24, 1980
K800297SANDARE FAST 340 PHOSPHOROUS PROCEDUREMarch 5, 1980
K792531SANDARE CHLORIDE PROCEDUREJanuary 11, 1980