Jay Hardy

FDA Filings

This page includes the latest FDA filings for Jay Hardy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8020667
• FEI Number: 4247
• Name: Jay Hardy
• Owner & Operator: MAST GROUP LTD.
• Contact Address: MAST HOUSE DERBY RD; BOOTLE GB-LIV Liverpool L20 1EA GB
• US Agent:
  • Jay Hardy
  • Hardy Diagnostics
  • 805 3462766
  • 805 6149274
  • HardyJ@HardyDiagnostics.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Hardy Diagnostics 1430 West McCoy Lane; Santa Maria, CA 93455 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K183298 | JTN Jay Hardy [MAST GROUP LTD.]	Hardydisk Omadacycline 30ug disks	2019-01-21
PMN K171975 | JTN Jay Hardy [MAST GROUP LTD.]	HardyDisk Delafloxacin 5ug Discs	2019-01-21
GTN Jay Hardy [MAST GROUP LTD.]	MAST ASSURE ANTISERA	2018-01-11
GST Jay Hardy [MAST GROUP LTD.]	MAST ASSURE ANTISERA	2018-01-11
PMN K994212 | JTN Jay Hardy [MAST GROUP LTD.]	AST Mezlocillin 75ug discs	2014-09-16
PMN K994063 | JTN Jay Hardy [MAST GROUP LTD.]	AST Aztreonam 30ug discs	2014-09-16
PMN K002663 | JTN Jay Hardy [MAST GROUP LTD.]	AST Netilmicin 30ug discs	2014-09-16
PMN K002661 | JTN Jay Hardy [MAST GROUP LTD.]	AST Cefotetan 30ug discs	2014-09-16
PMN K002660 | JTN Jay Hardy [MAST GROUP LTD.]	AST Lomefloxacin 10ug discs	2014-09-16
PMN K002369 | JTN Jay Hardy [MAST GROUP LTD.]	AST Gentamicin 120ug discs	2014-09-16
PMN K002368 | JTN Jay Hardy [MAST GROUP LTD.]	AST Streptomycin 300ug discs	2014-09-16
PMN K002367 | JTN Jay Hardy [MAST GROUP LTD.]	AST Ceftizoxime 30ug discs	2014-09-16
PMN K001490 | JTN Jay Hardy [MAST GROUP LTD.]	AST Cefonicid 30ug discs	2014-09-16
PMN K001489 | JTN Jay Hardy [MAST GROUP LTD.]	AST Cefoperazone 75ug discs	2014-09-16
PMN K000261 | JTN Jay Hardy [MAST GROUP LTD.]	AST Piperacillin/Tazobactam 110ug discs	2014-09-16
PMN K000201 | JTN Jay Hardy [MAST GROUP LTD.]	AST Streptomycin 10ug discs	2014-09-16
PMN K000022 | JTN Jay Hardy [MAST GROUP LTD.]	AST Cefamandole 30ug discs	2014-09-16
PMN K103538 | JTN Jay Hardy [MAST GROUP LTD.]	AST Ceftaroline 30 ug discs	2014-09-15
PMN K093807 | JTN Jay Hardy [MAST GROUP LTD.]	AST Televancin 30ug discs	2014-09-15
PMN K011385 | JTN Jay Hardy [MAST GROUP LTD.]	AST Neomycin 30ug discs	2014-09-15
PMN K003537 | JTN Jay Hardy [MAST GROUP LTD.]	AST Rifampicin 5ug discs	2014-09-15
PMN K003536 | JTN Jay Hardy [MAST GROUP LTD.]	AST Nafcillin 1ug disc	2014-09-15
PMN K003532 | JTN Jay Hardy [MAST GROUP LTD.]	AST Cefpodoxime 10ug discs	2014-09-15
JTR Jay Hardy [MAST GROUP LTD.]	Mast Cryobank	2013-01-21
JTR Jay Hardy [MAST GROUP LTD.]	Cryobank	2013-01-21
PMN K994150 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K994135 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K994134 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K994132 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K994129 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K994091 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K994089 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K994067 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K994051 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K994046 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K993994 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K993993 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy susceptibility test disks	2011-07-06
PMN K080019 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K062245 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K011384 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K011086 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K003690 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K003686 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K003556 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K003554 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K002664 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K002662 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K002656 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K001728 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K001487 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000526 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000525 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000524 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000509 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000440 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000305 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000304 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000302 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000272 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000271 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000268 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000259 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000258 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000203 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000183 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000182 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000181 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000175 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000130 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K000128 | JTN Jay Hardy [MAST GROUP LTD.]	Hardy Susceptibility test disks	2011-07-06
PMN K062864 | MYI Jay Hardy [MAST GROUP LTD.]	MASTALEX-MRSA	2006-11-28
LHL Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
KZI Jay Hardy [MAST GROUP LTD.]	MAST MEDIA	2006-09-07
JXA Jay Hardy [MAST GROUP LTD.]	BACTERURITEST	2006-09-07
JWX Jay Hardy [MAST GROUP LTD.]	MASTASTAPH	2006-09-07
JSK Jay Hardy [MAST GROUP LTD.]	MAST YEAST DIALYSATE	2006-09-07
JSJ Jay Hardy [MAST GROUP LTD.]	SELECTATAB OR SELECTAVIAL	2006-09-07
JSJ Jay Hardy [MAST GROUP LTD.]	MAST REDIPREP EGG MEDIA	2006-09-07
JSJ Jay Hardy [MAST GROUP LTD.]	MAST MEDIA	2006-09-07
JSI Jay Hardy [MAST GROUP LTD.]	SELECTATAB OR SELECTAVIAL	2006-09-07
JSI Jay Hardy [MAST GROUP LTD.]	MAST MEDIA	2006-09-07
JSH Jay Hardy [MAST GROUP LTD.]	SELECTATAB OR SELECTAVIAL	2006-09-07
JSH Jay Hardy [MAST GROUP LTD.]	MAST MEDIA	2006-09-07
JSG Jay Hardy [MAST GROUP LTD.]	SELECTATAB OR SELECTAVIAL	2006-09-07
JSG Jay Hardy [MAST GROUP LTD.]	MAST MEDIA	2006-09-07
JSF Jay Hardy [MAST GROUP LTD.]	MAST ID MEDIA	2006-09-07
JSE Jay Hardy [MAST GROUP LTD.]	MAST MEDIA	2006-09-07
JSD Jay Hardy [MAST GROUP LTD.]	MAST MEDIA	2006-09-07
JSC Jay Hardy [MAST GROUP LTD.]	MAST MEDIA	2006-09-07
JSA Jay Hardy [MAST GROUP LTD.]	MAST MEDIA	2006-09-07
GWC Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GTZ Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GTY Jay Hardy [MAST GROUP LTD.]	MASTASTREP	2006-09-07
GTC Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GTA Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GSS Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GSQ Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GSH Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GRP Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GRM Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GOY Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GNB Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
GNA Jay Hardy [MAST GROUP LTD.]	MAST-ASSURE ANTISERA	2006-09-07
JTO Jay Hardy [MAST GROUP LTD.]	HARDY DIFFERENTIATION DISKS	1999-01-06

Similar & Related FDA Registered Companies

• Hardy Diagnostics