The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest Cefotaxime.
Device ID | K981137 |
510k Number | K981137 |
Device Name: | ETEST CEFOTAXIME |
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 | 1998-03-30 |
Decision Date | 1998-06-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026376963 | K981137 | 000 |
03573026618650 | K981137 | 000 |