The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Clindamycin, 2mcg.
Device ID | K002662 |
510k Number | K002662 |
Device Name: | HARDYDISK CLINDAMYCIN, 2MCG |
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 | 2000-08-25 |
Decision Date | 2000-11-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816576020638 | K002662 | 000 |
00816576020621 | K002662 | 000 |