Product code JZH— Immunology
C3PA (GBG) PROPERDIN FACTOR B
- Classification name
- Factor B, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5320
- Advisory panel
- Immunology
- Total cleared
- 6
- First cleared
- Most recent
Market context for product code JZH
FDA has cleared devices under product code JZH between 1978 and 1997, filed by 6 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
- 1997
- 1988
- 1983
- 1981
- 1978
Top applicants under product code JZH
Recent clearances under product code JZH
- K964843 — IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT
- K882623 — PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM
- K831959 — RADIAL IMMUNO-TEST FOR HUMAN FACTOR B
- K811740 — KALLESTAD'S ENDOPLATE FACTOR B TEST
- K781016 — C3PA (GBG) PROPERDIN FACTOR B
- K772084 — LAS-R HUMAN C3 PROACTIVATOR TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.