ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800— 510(k) K051435
Substantially EquivalentClinical Micro Sensors
FDA 510(k) clearance K051435 for ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800, Substantially Equivalent on 2006-01-19. Applicant: Clinical Micro Sensors. Device class: 2.
Clearance details
- Applicant
- Clinical Micro Sensors
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.