Marion Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
38
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K883391POLYMER ADHESIVE BANDAGEMarch 23, 1989
K875182MODIFIED LABELING FOR TOXI-LAB THC SCREENJuly 5, 1988
K875181MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUMMay 27, 1988
K874554ENVICLUSIVE (TM)March 11, 1988
K874551ENVINET(TM)January 22, 1988
K874552ENVISAN PADJanuary 22, 1988
K874553ENVISAN PASTEDecember 18, 1987
K870864CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TESTApril 14, 1987
K863485MODIFICATION OF CDT(TM) CLOSTRIDIUM TESTSeptember 17, 1986
K862123BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICEJune 16, 1986
K853073CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.August 1, 1985
K852044CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXIJuly 19, 1985
K851399BAC-T-SCREENJune 4, 1985
K845008BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATEMarch 5, 1985
K833917BAC-T-SCREENJanuary 13, 1984
K831456TOXI-LAB CANNABINOID THC SCREENJune 30, 1983
K830372ARTIMICROBIAL REMOVAL DEVICEApril 8, 1983
K823850BAC-T-SCREEN BACTERIURIA DETECTION DEVMarch 1, 1983
K823523TOXI-LAB RAPID SCREENJanuary 14, 1983
K822344ANTIMICROBIAL REMOVAL DEVICE (ARD)August 25, 1982