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Reagent kit distribution approval for License 31-20841-01MA for Cadema Medical Products,Inc,authorizing distribution of Tc 99m-labeled antimony trisulfite colloid in Lymph-Scan ket,red blood cell kit & albumin colloid kit.
Accession Number: ML20128J937
Date Released: Sunday, October 27, 2024
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- ML20128J932 - Reagent kit distribution approval for License 31-20841-01MA for Cadema Medical Products,Inc,authorizing distribution of Tc 99m-labeled antimony trisulfite colloid in Lymph-Scan ket,red blood cell kit & albumin colloid kit. (2 page(s), 6/26/1985)
- ML20128J941 - Forwards License 31-20841-01MA,approving distribution of reagent kits.Actual color labels for diethylene triamine pentacetic acid kit vial & vial shield should be submitted. (2 page(s), 6/26/1985)
- ML20128J950 - Responds to NRC 850530 request for addl info re reagent kit distribution authorization.Antimony trisulfide colloid for lymph-scan not yet approved by FDA.Pentatate sodium kit under clinical study.Supporting documentation encl. (25 page(s), 6/12/1985)
- ML20128J959 - Requests addl info re 850415 application for authorization to distribute reagent kits,including FDA ltr of approval for NDA 19-180,ack of use of BNL IND 12003 & 841015 ltr re pentatate sodium kit. (4 page(s), 5/30/1985)
- ML20128J964 - Advises that application for authorization to distribute reagent kits to group medical licensees should be submitted or users of kits urged to submit individual applications for amends to licenses. (4 page(s), 3/21/1985)
- ML20128J967 - Forwards application for authorization to distribute listed reagent kits used w/Tc-99m to NRC group medical licensees. Each kit mfg,labeled & packaged per FDA regulations re investigational exemption. (1 page(s), 4/23/1985)
- ML20128J972 - Application for license,authorizing distribution of reagent kits.Fee paid. (26 page(s), 4/15/1985)
