Monobind - FDA 510(k) Cleared Devices
Recent clearances: ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300, FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300, T-UPTAKE MICROPLATE EIA
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Monobind Chemistry ✕
17 devices
Cleared
Aug 22, 2003
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
Chemistry
157d
Cleared
Apr 05, 2002
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
Chemistry
45d
Cleared
Feb 04, 1998
T-UPTAKE MICROPLATE EIA
Chemistry
26d
Cleared
Sep 02, 1997
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
Chemistry
43d
Cleared
Jun 24, 1997
THYROTROPIN(TSH) ELISA
Chemistry
41d
Cleared
Jun 24, 1997
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
Chemistry
32d
Cleared
Jun 16, 1997
TOTAL THROXINE MICROPLATE EIA(225-300)
Chemistry
39d
Cleared
Jun 16, 1997
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
Chemistry
33d
Cleared
Feb 25, 1993
TRIODOTHYRONINE (TC) COATED TUBE RIA
Chemistry
70d
Cleared
Jul 07, 1992
THYROXINE (T4) COATED TUBE RIA
Chemistry
74d
Cleared
Jan 28, 1986
HCG RIA TEST SYSTEM
Chemistry
48d
Cleared
Apr 05, 1983
RADIOIMMUNOASSAY TEST SYSTEM PRL
Chemistry
56d
Cleared
Apr 16, 1982
LH RADIOIMMUNOASSAY TEST SYSTEM
Chemistry
25d
Cleared
Feb 04, 1982
FSH RADIOIMMUNOASSAY TEST SYSTEM
Chemistry
27d
Cleared
Aug 04, 1977
T3 RIA TEST SYSTEM
Chemistry
30d
Cleared
Aug 04, 1977
T4 RIA TEST SYSTEM
Chemistry
30d
Cleared
Aug 04, 1977
TSH RIA TEST SYSTEM
Chemistry
30d