Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software— 510(k) K171664
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K171664 for Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software, Substantially Equivalent on 2017-09-13. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code GKA
- Device class
- Class 2
- Regulation
- 21 CFR 864.7415
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hercules, CA, US
Recent devices under product code GKA
view allMore clearances from Bio-Rad Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.