JZH
6 FDA 510(k) clearances · Product code
59 daysmedian time to decision
93 days90th percentile
6clearances measured
FDA profile
- Official device name
- Factor B, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5320
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT (K964843) | Beckman Instruments, Inc. | 1997-03-06 |
| PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM (K882623) | Technicon Instruments Corp. | 1988-07-08 |
| RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (K831959) | Kent Laboratories, Inc. | 1983-07-19 |
| KALLESTAD'S ENDOPLATE FACTOR B TEST (K811740) | Kallestad Laboratories, Inc. | 1981-07-16 |
| C3PA (GBG) PROPERDIN FACTOR B (K781016) | Icl Scientific | 1978-08-14 |
| LAS-R HUMAN C3 PROACTIVATOR TEST (K772084) | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 |
Track JZH automatically
Every clearance here is in the API, with alerts when new ones post.