SENSITITRE STABILITY PLATES— 510(k) K880641
Substantially EquivalentSensititre , Ltd.
FDA 510(k) clearance K880641 for SENSITITRE STABILITY PLATES, Substantially Equivalent on 1988-05-13. Applicant: Sensititre , Ltd.. Device class: 2.
Clearance details
- Applicant
- Sensititre , Ltd.
- Product code
- Code JWY
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salem, NH, US
Recent devices under product code JWY
view all- K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
- K260696 — MTS Gepotidacin 0.016-256 µg/mL
- K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
- K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
- 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
More clearances from Sensititre , Ltd.
view allRecalls naming K880641
K-number listed on FDA's recall record- Z-0327-2023 — Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
- Z-0328-2023 — Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
- Z-0329-2023 — Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
- Z-0330-2023 — Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
- Z-0331-2023 — Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
- Z-0332-2023 — Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
- Z-0333-2023 — Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
- Z-0334-2023 — Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
- Z-0335-2023 — Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K880641.
Data sourced from openFDA. This site is unofficial and independent of the FDA.