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Nichols Institute

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K952559ERYTHROPOIETIN IMMUNOASSAY KITMay 29, 1996
K952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)July 3, 1995
K946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3June 23, 1995
K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYMay 15, 1995
K932650ERYTHROPOIETIN IMMUNOASSAY KITMarch 11, 1994
K931600CHEMILUMINESCENCE FREE T3 IMMUNOASSAYSeptember 8, 1993
K931777APO A-1 CHEMILUMINESCENCE ASSAYAugust 16, 1993
K931601CHEMILUMINESCENCE DHEA-S IMMUNOASSAYJuly 27, 1993
K926396ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCTJuly 27, 1993
K931311THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KITMay 14, 1993
K930777THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KITApril 8, 1993
K924675TSH - THIRD GENERATION LOW CONTROLSNovember 18, 1992
K922676CORTISOL CHEMILUMINESCENCE ASSAYJuly 10, 1992
K920300B2-MICROGLOBULIN RADIOIMMUNOASSAYMarch 17, 1992
K903391ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMMOctober 12, 1990