Medical Device Manufacturer · US , Mchenry , IL

Monobind

21 submissions · 21 cleared · Since 1977
21
Total
21
Cleared
0
Denied

Monobind — FDA 510(k) Submissions

Monobind has submitted 21 FDA 510(k) premarket notifications since 1977, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Total Triiodothyronine, Radioimmunoassay, Follicle-stimulating Hormone, Radioimmunoassay, Prolactin (lactogen), Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine, Radioimmunoassay, Total Thyroxine . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
K030860 · KLI Enzyme Immunoassay,... · Chemistry
Aug 2003 157d
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
K020548 · CEC Radioimmunoassay, Free... · Chemistry
Apr 2002 45d
T-UPTAKE MICROPLATE EIA
K980088 · KHQ Radioassay,... · Chemistry
Feb 1998 26d
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
K972720 · CGJ Radioimmunoassay,... · Chemistry
Sep 1997 43d
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834 · JNL Immunochemical,... · Immunology
Jul 1997 45d
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
K971835 · DDC Thyroglobulin, Antigen,... · Immunology
Jul 1997 45d
THYROTROPIN(TSH) ELISA
K971780 · JLW Radioimmunoassay,... · Chemistry
Jun 1997 41d
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
K971921 · CFT Radioimmunoassay,... · Chemistry
Jun 1997 32d
TOTAL THROXINE MICROPLATE EIA(225-300)
K971709 · KLI Enzyme Immunoassay,... · Chemistry
Jun 1997 39d
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
K971779 · CDP Radioimmunoassay, Total... · Chemistry
Jun 1997 33d
TRIODOTHYRONINE (TC) COATED TUBE RIA
K926345 · CDP Radioimmunoassay, Total... · Chemistry
Feb 1993 70d
DIGOXIN COATED TUBE RIA
K922353 · LCS Radioimmunoassay, Digoxin... · Toxicology
Aug 1992 97d
THYROXINE (T4) COATED TUBE RIA
K921935 · CDX Radioimmunoassay, Total... · Chemistry
Jul 1992 74d
HCG RIA TEST SYSTEM
K854958 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jan 1986 48d
RADIOIMMUNOASSAY TEST SYSTEM PRL
K830412 · CFT Radioimmunoassay,... · Chemistry
Apr 1983 56d
LH RADIOIMMUNOASSAY TEST SYSTEM
K820760 · CEP Radioimmunoassay,... · Chemistry
Apr 1982 25d
FSH RADIOIMMUNOASSAY TEST SYSTEM
K820048 · CGJ Radioimmunoassay,... · Chemistry
Feb 1982 27d
T3 UPTAKE TEST
K780361 · KHQ Radioassay,... · Immunology
Mar 1978 16d
T3 RIA TEST SYSTEM
K771220 · CDP Radioimmunoassay, Total... · Chemistry
Aug 1977 30d
T4 RIA TEST SYSTEM
K771221 · CDX Radioimmunoassay, Total... · Chemistry
Aug 1977 30d
TSH RIA TEST SYSTEM
K771222 · JLW Radioimmunoassay,... · Chemistry
Aug 1977 30d
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