Alpha-Tec Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K053257PARA-PRO FC50May 12, 2006
K890861ATS DOBELL & O'CONNOR'S IODINEMarch 23, 1989
K890020ATS LUGOL'S IODINE SOLUTIONFebruary 24, 1989
K890148ATS TB RAPID STAIN SET PRODUCT #034-45January 24, 1989
K890022ATS MAYER'S ALBUMINJanuary 10, 1989
K883048ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTIONAugust 17, 1988
K883049ATS PARA-SET IODINE ALCOHOL SOLUTIONAugust 17, 1988
K883062ATS SCHAUDINN'S FIXATIVE W/ACETIC ACIDAugust 4, 1988
K881949ATS NAC-PAC SETMay 25, 1988
K881879ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42May 13, 1988
K880989ATS CRYPTOSPORIDIUM STAIN SETMay 13, 1988
K881698ATS PVA FIXATIVE SOLUTIONMay 13, 1988
K880962ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDESMarch 30, 1988
K881042ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)March 30, 1988
K880990ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTIONMarch 24, 1988
K823704ATS GRAM STAIN CONTROL SLIDEJanuary 7, 1983
K823706ATS AFB STAIN CONTROL SLIDEJanuary 7, 1983
K823705ATS PARASITOLOGY STAIN CONTROL SLIDEJanuary 7, 1983