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withdrawn,object_id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-0159-0008,FDA,FDA-2016-P-0159,Reference 1 - Guidance - Procedures for Class II Device Exemptions from Premarket Notification 1998,Supporting & Related Material,Guidance,2016-10-04T04:00:00Z,2016,10,,,2016-10-04T16:55:57Z,,0,0,0900006482295b64
FDA-2016-P-0159-0007,FDA,FDA-2016-P-0159,"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,,2016-10-04T15:42:52Z,2016-23901,0,0,09000064822912df
FDA-2016-P-0159-0006,FDA,FDA-2016-P-0159,Denial letter from the FDA CDRH to Biorex Labs LLC,Other,Denial of Petition,2016-07-12T04:00:00Z,2016,7,2016-07-12T04:00:00Z,,2016-07-12T17:23:39Z,,0,0,09000064820a44c0
FDA-2016-P-0159-0005,FDA,FDA-2016-P-0159,"Medical Devices; Exemption From Premarket Notification: Method, 
Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in 
a Reagent Tablet Format",Notice,Announcement,2016-05-04T04:00:00Z,2016,5,2016-05-04T04:00:00Z,2016-06-04T03:59:59Z,2016-05-04T14:42:25Z,2016-10388,0,0,0900006481fa8786
FDA-2016-P-0159-0003,FDA,FDA-2016-P-0159,"Medical Devices; Exemption From Premarket Notification: Method,
Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a
Reagent Tablet Format",Notice,Request for Comments,2016-03-24T04:00:00Z,2016,3,2016-03-24T04:00:00Z,2016-04-26T03:59:59Z,2016-03-24T13:55:03Z,2016-06709,0,0,0900006481edc6ef
FDA-2016-P-0159-0004,FDA,FDA-2016-P-0159,"Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff re Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format",Supporting & Related Material,Background Material,2016-03-24T04:00:00Z,2016,3,,,2016-03-28T19:32:37Z,,0,0,0900006481edd298
FDA-2016-P-0159-0001,FDA,FDA-2016-P-0159,Citizen Petition from Biorex Labs LLC,Other,Citizen Petition,2016-01-19T05:00:00Z,2016,1,2016-01-19T05:00:00Z,,2024-11-11T21:22:37Z,,1,0,0900006481e0efaf
FDA-2016-P-0159-0002,FDA,FDA-2016-P-0159,Acknowledgement Letter from FDA DDM to Biorex Labs LLC,Other,Acknowledgement Letter/Receipt,2016-01-19T05:00:00Z,2016,1,2016-01-19T05:00:00Z,,2016-01-19T21:40:02Z,,0,0,0900006481e10188