The following data is part of a premarket notification filed by Ab Biodisk with the FDA for The E Test, Modification.
| Device ID | K913459 |
| 510k Number | K913459 |
| Device Name: | THE E TEST, MODIFICATION |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AB BIODISK PYRAMIDVAGEN 7 Solna, SE S-171 36 |
| Contact | Anne Bolmstrom |
| Correspondent | Anne Bolmstrom AB BIODISK PYRAMIDVAGEN 7 Solna, SE S-171 36 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-05 |
| Decision Date | 1991-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026376703 | K913459 | 000 |
| 03573026253103 | K913459 | 000 |
| 03573026253158 | K913459 | 000 |
| 03573026618612 | K913459 | 000 |
| 03573026619701 | K913459 | 000 |
| 03573026618292 | K913459 | 000 |
| 03573026619619 | K913459 | 000 |
| 03573026623593 | K913459 | 000 |
| 03573026619855 | K913459 | 000 |
| 03573026619800 | K913459 | 000 |
| 03573026619886 | K913459 | 000 |
| 03573026624453 | K913459 | 000 |
| 03573026252649 | K913459 | 000 |
| 03573026252847 | K913459 | 000 |
| 03573026252922 | K913459 | 000 |
| 03573026378189 | K913459 | 000 |
| 03573026378912 | K913459 | 000 |
| 03573026378455 | K913459 | 000 |
| 03573026378417 | K913459 | 000 |
| 03573026550189 | K913459 | 000 |
| 03573026377557 | K913459 | 000 |
| 03573026377328 | K913459 | 000 |
| 03573026377021 | K913459 | 000 |
| 03573026549978 | K913459 | 000 |
| 03573026252366 | K913459 | 000 |
| 03573026253592 | K913459 | 000 |
| 03573026256685 | K913459 | 000 |