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Seragen Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K872148VIVID CHLAMYDIA(TM)August 19, 1987
K851663QUICK-COUNT HEMATOLOGY CONTROLSJuly 23, 1985
K852260QUICK-CHEM CALIBRATION SETJuly 22, 1985
K851520CK/LD ISOENZYMES CONTROLS(HUMAN)June 25, 1985
K851521LD-1(IMMUNO) SEPARATION SETMay 10, 1985
K850209QUICK-LYTEFebruary 27, 1985
K844743SERATEST ENA(RNP/SM) DETERMINATIONFebruary 4, 1985
K842563SERATEST DNA DETERMINATIONOctober 25, 1984
K841504QUICK-COUNT PLUS 2June 11, 1984
K840793CK/MB IMMUNO-ISOENZYME CONTROL SERUMApril 13, 1984
K840863SERATEST RF LATEX DETERMINATIONApril 4, 1984
K834396DIRECT IRON REAGENT SETFebruary 21, 1984
K833972QUICK-COUNT HEMATOLOGY REAGENT KITFebruary 17, 1984
K833971QUICK-COUNTJanuary 30, 1984
K833931UREA NITROGEN-UVJanuary 13, 1984
K833744ALKALINE PHOSPHATASE-RATEJanuary 13, 1984
K832926ENZYMATIC GLUCOSE DETERMINATIONOctober 28, 1983
K832759TOTAL IRON-BINDING CAPACITY ACCESORYOctober 14, 1983
K831525H-FLU B ELISA TESTSeptember 29, 1983
K822115SERAGAN ACTH125 I-RIA KITOctober 18, 1982