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Monobind

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K181017Free Testosterone AccuBind ELISA Test SystemJuly 20, 2018
K063437ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300April 4, 2008
K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300August 22, 2003
K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300April 5, 2002
K980088T-UPTAKE MICROPLATE EIAFebruary 4, 1998
K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)September 2, 1997
K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAJuly 3, 1997
K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJuly 3, 1997
K971780THYROTROPIN(TSH) ELISAJune 24, 1997
K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAJune 24, 1997
K971709TOTAL THROXINE MICROPLATE EIA(225-300)June 16, 1997
K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIAJune 16, 1997
K926345TRIODOTHYRONINE (TC) COATED TUBE RIAFebruary 25, 1993
K922353DIGOXIN COATED TUBE RIAAugust 24, 1992
K921935THYROXINE (T4) COATED TUBE RIAJuly 7, 1992
K854958HCG RIA TEST SYSTEMJanuary 28, 1986
K830412RADIOIMMUNOASSAY TEST SYSTEM PRLApril 5, 1983
K820760LH RADIOIMMUNOASSAY TEST SYSTEMApril 16, 1982
K820048FSH RADIOIMMUNOASSAY TEST SYSTEMFebruary 4, 1982
K780361T3 UPTAKE TESTMarch 22, 1978