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Orion Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
12

Recent 510(k) Clearances

K-NumberDeviceDate
K912391RUBALEX, MODIFICATIONMay 4, 1992
K901637RESUBMITTED MODIFIED RUBALEXApril 26, 1990
K884650RESUBMITTED SCANORAMarch 16, 1989
K890199DENTOCULT SM-STRIP MUTANSMarch 2, 1989
K881506MAMEX DC MAG MG12June 10, 1988
K881505MAMEX DC MG11June 10, 1988
K874040MAMEX DC S SL10/MG14November 23, 1987
K872744MODIFIED CHLAMYSET ANTIGENSeptember 22, 1987
K864457CHLAMYSET ANTIBODY EIASeptember 11, 1987
K872301DENTOCULT-SM CULTURE-PADDLESeptember 11, 1987
K872058ORICULT-N CULTURE-PADDLEJune 10, 1987
K861882IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN BOctober 29, 1986
K861883IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1October 29, 1986
K863730MYOLEXOctober 15, 1986
K862671MICROALBUMINURIA ASSAYSeptember 18, 1986
K860679IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEINAugust 4, 1986
K861881RUBALEX (REVISED VERSION)June 4, 1986
K853401CHLAMYSET ANTIGENApril 28, 1986
K852788RUBALEXMarch 12, 1986
K860529ROTALEXMarch 4, 1986