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Medical Specialties, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
40
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K946201STAND, INFUSIONApril 18, 1995
K931947CHECKPOINTJune 18, 1993
K926095REFRACTROL-SPJanuary 26, 1993
K924926MSI-HCTJanuary 7, 1993
K896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEFebruary 9, 1990
K883703MSI-CAL 7November 22, 1988
K883850MSI-CAL 16November 22, 1988
K883851MSI-CAL 8November 22, 1988
K880608MSI-PCMarch 21, 1988
K880270MSI-DIFF PLUSMarch 1, 1988
K872140(MSI) PATH-SAVERJune 15, 1987
K871067MSI HEMATOLOGY CONTROL +March 25, 1987
K860501FLAME PHOTOMETER STANDARDApril 7, 1986
K853776MSI-HB HEMOGLOBIN CONTROLSeptember 19, 1985
K841060SGPT REAGENT SETMay 1, 1984
K841055GLUCOSE ENZYMATIC REAGENT SETMay 1, 1984
K841069SERUM TOTAL PROTEIN REAGENT SETMay 1, 1984
K841053CHOLESTEROL REAGENT SET ENZYMATICMay 1, 1984
K841059SGPT REAGENT SETMay 1, 1984
K841050TOTAL BILIRUBIN REAGENT SETMay 1, 1984