510(k) K052366
- Device
- ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
- Applicant
- AB BIODISK
- 510(k) number
- K052366
- Product code
- JWY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-10-13
- Date received
- 2005-08-29
- Regulation
- 866.1640
- Classification name
- Manual Antimicrobial Susceptibility Test Systems
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNE BOLMSTROM
- Address
- Dalvagen 10 Solna SE 16956 16956
FDA Registration Numbers#
- 3003750284
- 1119779
- 3013661582
- 1924669
- 3012389632
- 2919016
- 9615754
- 1530126
- 8021914
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JWY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | 2026-04-21 |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | 2026-04-17 |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | 2025-10-02 |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Thermo Fisher Scientific | 2025-09-25 |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Thermo Fisher Scientific | 2025-09-05 |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | Thermo Fisher Scientific | 2025-08-28 |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem s.r.l. | 2025-08-20 |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific | 2025-06-30 |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Thermo Fisher Scientific | 2025-06-20 |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | Biomérieux | 2025-06-12 |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | Thermo Fisher Scientific | 2025-05-22 |
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | Biomerieux S.A. | 2025-04-30 |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific | 2025-04-15 |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | Thermo Fisher Scientific | 2025-02-10 |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | Thermo Fisher Scientific | 2025-02-10 |
Legacy Summary#
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FDA Review#
Decision Summary