The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest For Ceftazidime.
Device ID | K971694 |
510k Number | K971694 |
Device Name: | ETEST FOR CEFTAZIDIME |
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 | 1997-05-07 |
Decision Date | 1997-06-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026377106 | K971694 | 000 |
03573026252687 | K971694 | 000 |
03573026618704 | K971694 | 000 |