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Monoclonal Antibodies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K874863RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)February 16, 1988
K871726OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)July 27, 1987
K863744HCG CONTROL KITNovember 5, 1986
K860924RAMP PROGESTURINE PDG ASSAY--48 TEST KITJuly 2, 1986
K854611RAMP URINE HCG ASSAYDecember 30, 1985
K850730MODEL SERUM HCG ASSAYApril 2, 1985
K850480OVU STICK SELF-TEST -MODIFICATIONMarch 5, 1985
K843284OVUSTICK SELF-TESTDecember 11, 1984
K840738PLUS URINE HCG ASSAYApril 19, 1984
K840412OVU STICK URINE HLH KITApril 13, 1984
K833504PREGNASTICK URINE HCG KITJanuary 9, 1984
K832562SERUM HCG ASSAYSeptember 12, 1983
K831155B-CLONE HCG ASSAYJune 2, 1983
K822520MODEL UCG ASSAYSeptember 28, 1982