Medix Biotech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
39
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)September 8, 1995
K952319CONTRAST & RAPID HCG URINE/SERUM TSTJune 20, 1995
K932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010July 18, 1994
K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITSeptember 28, 1993
K925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITDecember 28, 1992
K924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100November 25, 1992
K922047IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064August 5, 1992
K921700TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093June 29, 1992
K920712MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KITMarch 27, 1992
K920345PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)March 18, 1992
K920299MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KITMarch 4, 1992
K920504MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KITMarch 2, 1992
K920253MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KITFebruary 14, 1992
K920046MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KITJanuary 28, 1992
K914756ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KITJanuary 15, 1992
K915208FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057December 18, 1991
K914696MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011November 13, 1991
K901345MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050May 10, 1990
K897144THYROXIN(T4) ENZYME IMMUNOASSAY TEST KITMarch 15, 1990
K896587MODIFIED HCG ENZYME IMMUNOASSAY TEST KITFebruary 16, 1990