| Device Type ID | 3375 |
| Device Name | Manual Antimicrobial Susceptibility Test Systems |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.1640 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JWY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 3375 |
| Device | Manual Antimicrobial Susceptibility Test Systems |
| Product Code | JWY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| CFR Regulation Number | 866.1640 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMERIEUX | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOMERIEUX SA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BIOMERIEUX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FISHER SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 20 | |
LIOFILCHEM S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
THERMO FISHER SCIENTIFIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 20 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 28 |
Incorrect Or Inadequate Test Results | 16 |
Low Readings | 3 |
Device Inoperable | 2 |
High Readings | 2 |
Low Test Results | 2 |
Insufficient Information | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
False Positive Result | 1 |
| Total Device Problems | 57 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Oct-02-2018 |
| 2 | Beckman Coulter, Inc. | II | Apr-27-2015 |
| 3 | Beckman Coulter, Inc. | II | Apr-27-2015 |
| 4 | Beckman Coulter, Inc. | II | Apr-26-2015 |
| 5 | Becton Dickinson & Co. | II | Dec-23-2015 |
| 6 | Becton Dickinson & Co. | II | Sep-12-2014 |
| 7 | BioMerieux SA | II | Dec-19-2017 |
| 8 | BioMerieux SA | II | May-03-2017 |
| 9 | BioMerieux SA | II | May-03-2017 |
| 10 | BioMerieux SA | II | Mar-21-2017 |
| 11 | BioMerieux SA | II | Feb-21-2017 |
| 12 | BioMerieux SA | II | Jul-01-2015 |
| 13 | Biomerieux | I | Dec-23-2015 |
| 14 | Biomerieux | III | Nov-19-2014 |