New England Nuclear

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K841478RIANEN CYCLIC-AMP RADIOIMMUNOASSAYJune 14, 1984
K840301RIANEN ESTRIOL RADIOIMMUNOASSAY KITMarch 30, 1984
K834038RIANEN FOLLICLE STIMULATING HORMONEJanuary 30, 1984
K833376RIANEN LUTEINIZING HORMONE RIA KITDecember 20, 1983
K831345RIANEN PROLACTIN 125I KITJune 8, 1983
K801245ATOMLIGHT (LIQUID SCINTILLATION SOLUTIONJune 20, 1980
K792175RIANEN, VITAMIN B12 ASSAY SYSTEMNovember 13, 1979
K790817RIA KIT, QUANTITATION OF PROSTATIC ACIDMay 7, 1979
K782110RIA KIT, RIANEN CORTISOLJanuary 26, 1979
K781888ASSAY SYSTEM, FERRITIN I KITJanuary 10, 1979
K781495RIANEN ASSAY SYSTEM, 125I KITSeptember 14, 1978
K780182TOBRAMYCIN 125I RIA KITFebruary 13, 1978
K772425RIANEN GENTAMICIN RIA KITJanuary 5, 1978
K772323RIANEN ESTRIOL RIA KITJanuary 5, 1978
K771590THYROID STIMULATING HORMONESeptember 15, 1977
K761346RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)January 7, 1977
K760619RADIO IMMUNO ASSAY KIT/December 6, 1976
K760068KIT, RIA, GENTAMICIN SULF.July 20, 1976