The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Rifampin, 5mcg.
Device ID | K003537 |
510k Number | K003537 |
Device Name: | HARDYDISK RIFAMPIN, 5MCG |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
Contact | Melissa M Traylor |
Correspondent | Melissa M Traylor 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 | 2000-11-16 |
Decision Date | 2001-01-12 |