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Amend 14 to License 21-14161-01G for Nuclear Diagnostics, Inc,amending license in entirety.

Accession Number: ML20151L063

Date Released: Monday, October 28, 2024

Package Contents

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• ML20151L084 - Forwards Amend 14,renewing License 21-14161-01G.Per labelling requirements of 10CFR32.71,final source container must bear required labels & wording,including phrase, "Not for Internal or External Use on Humans or Animals." (1 page(s), 10/5/1987)
• ML20151L151 - Responds to request for addl info re labelling.Licensee proposes to add small label to reagent bottle w/statement "Not for Internal or External Use in Humans or Animals." Package & reagent lablels for all products encl. (2 page(s), 7/30/1987)
• ML20151L201 - Discusses review of labels to show that licensee meets 21CFR32.71(c)(2) requirements & contain statement "Not for Internal or External Use in Humans or Animals." Continued use of printed labels requested. (17 page(s), 7/16/1987)
• ML20151L215 - Requests listed addl info re 870610 application for renewal of License 21-14161-01G,including samples of reagent bottle labels & brochures for kits mfg by Farmos Diagnostica.Record of 870513 telcon encl. (2 page(s), 6/24/1987)
• ML20151L530 - Responds to 870414 request for addl info & subsequent telcon.Revs to "Warnings & Precautions," will be included in each new reprinting of licensee brochure.Actual labels for primary reagents from mfg kits encl.W/o encl. (2 page(s), 6/10/1987)
• ML20151L571 - Application for renewal of License 21-14161-01G,authorizing use of I-125 in in vitro kits.Supporting documentation encl. Fee paid. (12 page(s), 6/10/1987)
• ML20151L616 - Requests extension of time in order to respond to 870414 request for addl info.Ltr indicating need for info only found recently after going through files of individual no longer working for licensee. (1 page(s), 5/8/1987)
• ML20151L770 - Requests addl info to support 861126 application for renewal of License 21-14161-01G.Recommends licensee make commitment that all brouchures will change at next printing date & new brochure be distributed after old stock depleted. (2 page(s), 4/14/1987)
• ML20151L786 - Ack receipt of application for renewal of License 21-14161-01G. (1 page(s), 12/19/1986)
• ML20151L795 - Forwards application for renewal of License 21-14161-01G. (1 page(s), 11/26/1986)
• ML20151L799 - Application for renewal of License 21-14161-01G. (7 page(s), 11/26/1986)