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Meridian Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
92
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K993914PREMIER TOXINS A&B, MODEL 616096December 10, 1999
K990263IMMUNOCARD STAT! E. COLI O157:H7August 9, 1999
K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTJune 25, 1999
K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTJune 25, 1999
K983255MODIFICATION TO: PREMIER PLATINUM HPSADecember 17, 1998
K982764PREMIER CRYPTOSPORIDIUMDecember 3, 1998
K982711PREMIER GIARDIANovember 25, 1998
K980076PREMIER PLATINUM HPSAMay 12, 1998
K980077PARA-PAK SPINCONApril 2, 1998
K971585IMMUNOCARD STAT! ROTAVIRUSAugust 20, 1997
K961508IMMUNOCARD H. PYLORIJanuary 21, 1997
K953839PREMIER HSV PLUSMay 23, 1996
K955859IMMUNOCARD TOXIN AApril 18, 1996
K953362PREMIER EHECNovember 14, 1995
K950167PREMIER EHECApril 14, 1995
K945558PREMIER(TM) H. PYLORYMarch 3, 1995
K941560IMMUNOCARD H. PYLORIDecember 8, 1994
K943228MICROSPORIDIUM CONTROL SETOctober 27, 1994
K934550IMMUNOCARD MYCOPLASMASeptember 20, 1994
K933587IMMUNOCARD ROTAVIRUSFebruary 3, 1994