The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest Esbl Ct/ctl Strip; Etest Esbl Tz/tzl Strip.
Device ID | K001547 |
510k Number | K001547 |
Device Name: | ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP |
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 | 2000-05-18 |
Decision Date | 2000-08-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026256760 | K001547 | 000 |
03573026256753 | K001547 | 000 |
03573026624354 | K001547 | 000 |
03573026624330 | K001547 | 000 |