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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
K883850MSI-CAL 16November 22, 1988
K883851MSI-CAL 8November 22, 1988
K883703MSI-CAL 7November 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
K841064ALKALINE PHOSPHOTASE REAGENT SETMay 1, 1984
K841054DIRECT GLUCOSE REAGENT SETMay 1, 1984
K841058LDH-UV REAGENT SETMay 1, 1984
K841056HDL PRECIPITANT REAGENT SETMay 1, 1984
K841062TRIGLYCERIDE REAGENT SETMay 1, 1984
K841053CHOLESTEROL REAGENT SET ENZYMATICMay 1, 1984