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American Scientific Products

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K864824INFECTIOUS TISSUE KITDecember 24, 1986
K844042BLOOD DILUTION VIALOctober 23, 1984
K831634GLUCOSE REAGENT B6360-11July 19, 1983
K831625UREA NITROGEN-BUN-REAGENTS B6360-12July 7, 1983
K831626UREA NITROGEN-BUN-REAGENTS B6370-11AJuly 7, 1983
K831624GLUCOSE REAGENT KITS-B6370-10AJuly 6, 1983
K831628CREATININE REAGENTS B6370-13July 6, 1983
K831627CREATININE REAGENTS B6360-10July 6, 1983
K831571ROTORJune 30, 1983
K831569REAGENT CUPSJune 30, 1983
K822799STREPTACOCCUS CO-AGGLUTINATION KITDecember 19, 1982
K822988COAGULASE PLASMA-CITRATED & EDTANovember 5, 1982
K822870STOOL-COLLECTION/PRESERVATION KITNovember 1, 1982
K821660BIO-CHECK GRAM STAIN CONTROLJune 25, 1982
K820683STAPHYLOCOCCUS LATEX AGGLUTINATION KITApril 14, 1982
K820533B4182-1April 8, 1982
K820532DISPO FIBRIN PIPET TIPS B4182-2April 8, 1982
K813359MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGLDecember 31, 1981
K812190COCCIDIOIDES IMMUNODIFFUSION SYSTEMAugust 31, 1981
K812194IMMUNODIFFUSION BAND INTENSIFYING FLUIDAugust 31, 1981