Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

System, Hemoglobin, Automated

FDA product code GKR · 39 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.5620
Review panel
HE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1977-10-07 – 2020-08-04
↑