The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Compound Sulphonamides Antimicrobial Susceptibility Test Disc.
Device ID | K971637 |
510k Number | K971637 |
Device Name: | COMPOUND SULPHONAMIDES 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 | 1997-05-02 |
Decision Date | 1997-12-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384006045 | K971637 | 000 |