THE E TEST, MODIFICATION
FDA 510(k) clearance K913459 · decided 1991-09-25
Clearance details
- K-number
- K913459
- Device name
- THE E TEST, MODIFICATION
- Applicant
- Ab Biodisk
- Decision
- Substantially Equivalent
- Date received
- 1991-08-05
- Decision date
- 1991-09-25
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- JWY
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Solna, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252 recall (Z-0819-2023) | Biomerieux Inc | 2023-01-04 |
| ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333 recall (Z-0823-2023) | Biomerieux Inc | 2023-01-04 |
| ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determini recall (Z-0264-2018) | BioMerieux SA | 2017-12-19 |
| ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determini recall (Z-0265-2018) | BioMerieux SA | 2017-12-19 |
| ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETES recall (Z-1522-2017) | BioMerieux SA | 2017-03-21 |
| ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). E recall (Z-1530-2017) | BioMerieux SA | 2017-03-21 |