The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Meropenem Antimicrobial Susceptibility Test Disc.
Device ID | K983718 |
510k Number | K983718 |
Device Name: | MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
Contact | Andy Hollingsworth |
Correspondent | Andy Hollingsworth OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
Product Code | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-21 |
Decision Date | 1998-12-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384007004 | K983718 | 000 |