The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Ast Telavancin,30ug.
Device ID | K093807 |
510k Number | K093807 |
Device Name: | HARDYDISK AST TELAVANCIN,30UG |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
Contact | Wendy Philips |
Correspondent | Wendy Philips HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
Product Code | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-11 |
Decision Date | 2010-01-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816576021895 | K093807 | 000 |
00816576021888 | K093807 | 000 |