ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8— 510(k) K090901
Substantially EquivalentOsmetech Molecular Diagnostics
FDA 510(k) clearance K090901 for ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8, Substantially Equivalent on 2009-07-06. Applicant: Osmetech Molecular Diagnostics. Device class: 2.
Clearance details
- Applicant
- Osmetech Molecular Diagnostics
- Product code
- Code NUA
- Device class
- Class 2
- Regulation
- 21 CFR 866.5900
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pasadena, CA, US
Recent devices under product code NUA
view all- K163336 — xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
- K163347 — xTAG Cystic Fibrosis 39 Kit v2
- K083845 — XTAG CF60 KIT V2
- K083846 — XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
- K083294 — VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
More clearances from Osmetech Molecular Diagnostics
view allRecalls naming K090901
K-number listed on FDA's recall record- Z-2208-2020 — EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
- Z-2209-2020 — EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090901.
Data sourced from openFDA. This site is unofficial and independent of the FDA.