The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Trimethoprim/sulphamethoxazole.
Device ID | K983027 |
510k Number | K983027 |
Device Name: | TRIMETHOPRIM/SULPHAMETHOXAZOLE |
Classification | Manual Antimicrobial Susceptibility Test Systems |
Applicant | AB BIODISK DALVAGEN 10 Solna, SE 16956 |
Contact | Anne Bolmstrom |
Correspondent | Anne Bolmstrom AB BIODISK DALVAGEN 10 Solna, SE 16956 |
Product Code | JWY |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-31 |
Decision Date | 1998-10-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026378899 | K983027 | 000 |
03573026253271 | K983027 | 000 |
03573026623548 | K983027 | 000 |