id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2016-P-1026-0006,FDA,FDA-2016-P-1026,"Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format",Rule,Final Rule,2016-10-04T04:00:00Z,2016,10,2016-10-04T04:00:00Z,,2016-10-04T16:10:04Z,2016-23899,0,0,0900006482291406 FDA-2016-P-1026-0007,FDA,FDA-2016-P-1026,Reference 1 - Guidance - Procedures for Class II Device Exemptions from Premarket Notification 1998,Supporting & Related Material,Guidance,2016-10-04T04:00:00Z,2016,10,,,2016-10-04T16:53:15Z,,0,0,0900006482295b63 FDA-2016-P-1026-0005,FDA,FDA-2016-P-1026,Letter from CDRH to Germaine Laboratories Inc,Other,Denial,2016-09-12T04:00:00Z,2016,9,2016-09-12T04:00:00Z,,2016-09-12T16:09:54Z,,0,0,09000064821fad0d FDA-2016-P-1026-0003,FDA,FDA-2016-P-1026,"Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format; Republication",Notice,Notice of Publication,2016-06-20T04:00:00Z,2016,6,2016-06-20T04:00:00Z,2016-07-21T03:59:59Z,2016-06-20T12:09:47Z,2016-14459,0,0,090000648204fcd6 FDA-2016-P-1026-0004,FDA,FDA-2016-P-1026,Reference 1 - Guidance for Industry and CDRH Staff on Procedures for Class II Device Exemptions from Premarket Notification,Supporting & Related Material,Background Material,2016-06-20T04:00:00Z,2016,6,,,2024-11-07T23:47:40Z,,0,0,090000648204943e FDA-2016-P-1026-0002,FDA,FDA-2016-P-1026,"Acknowledgement Letter from FDA DDM to Germaine Laboratories, Inc.",Other,Acknowledgement Letter/Receipt,2016-03-23T04:00:00Z,2016,3,2016-03-23T04:00:00Z,,2016-03-23T13:02:51Z,,0,0,0900006481ed6723 FDA-2016-P-1026-0001,FDA,FDA-2016-P-1026,"Citizen Petition from Germaine Laboratories, Inc.",Other,Citizen Petition,2016-03-23T04:00:00Z,2016,3,2016-03-23T04:00:00Z,,2024-11-12T06:05:46Z,,1,0,0900006481ed61cd