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Diatech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K881685FIBRINOGENTEST-OAugust 9, 1988
K854938COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.March 12, 1986
K854090DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENTJanuary 6, 1986
K854089DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENTJanuary 6, 1986
K842286DIA T1, T2 & T3September 11, 1984
K841462HEPARIN COAGULATION CONTROL PLASMA 1-June 1, 1984
K841523OWREN'S VERONAL BUFFERRJune 1, 1984
K841366DIA FIBRINJune 1, 1984
K841365DIA REPTINJune 1, 1984
K841461COAGULATION CONTROL PLASMA LEVEL 1/2/3May 2, 1984
K840802DIA THROMBIN DIA PLASTINMay 1, 1984
K840928FACTOR DEFICIENT SUBSTRATE PLASMA VIIIApril 30, 1984
K840927FACTOR DEFICIENT SUBSTRATE PLASMA IIApril 30, 1984
K841522CALCIUM CHLORIDEApril 30, 1984
K840801DIA-H 1/2/3 & DIA-HT 1/2/3April 25, 1984
K840288DIACELINApril 23, 1984
K834571FIBRINOGEN TESTFebruary 4, 1984