Product code LKZ— Hematology
COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE
- Classification name
- Red-Cell Count By Photometry
- Device class
- Class 2
- Regulation
- 21 CFR 864.7100
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LKZ
FDA has cleared devices under product code LKZ between 1983 and 1984, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1984
- 1983
Top applicants under product code LKZ
Recent clearances under product code LKZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.