The following data is part of a premarket notification filed by General Diagnostics with the FDA for Piperacillin 100mcg. Antimicrobial.
Device ID | K820019 |
510k Number | K820019 |
Device Name: | PIPERACILLIN 100MCG. ANTIMICROBIAL |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | GENERAL DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-05 |
Decision Date | 1982-01-29 |