Product code LIM— Hematology
FETAL D TECTION KIT
- Classification name
- Test, Screening, For D Positive Fetal Rbc'S
- Device class
- Class 2
- Regulation
- 21 CFR 864.7455
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LIM
FDA has cleared devices under product code LIM between 1982 and 1998, 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
- 1998
- 1982
Top applicants under product code LIM
Recent clearances under product code LIM
Data sourced from openFDA. This site is unofficial and independent of the FDA.