FDA product code JZH: Factor B, Antigen, Antiserum, Control
JZH is the FDA product code for factor b, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5320 and reviewed by the Immunology panel. FDA has cleared 6 510(k) submissions under JZH, from 6 different applicants. The average 510(k) review took 51 days (median 46). FDA has posted 1 recall for JZH devices.
Classification
| Field | Value |
|---|---|
| Device name | Factor B, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5320 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZH clearance
Top JZH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 1 | 1997-03-06 |
| Technicon Instruments Corp. | 1 | 1988-07-08 |
| Kent Laboratories, Inc. | 1 | 1983-07-19 |
| Kallestad Laboratories, Inc. | 1 | 1981-07-16 |
| Icl Scientific | 1 | 1978-08-14 |
1 more applicants have JZH clearances. See the full list in Caduvo.
Most recent JZH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964843 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT | 1997-03-06 | 93 |
| K882623 | Technicon Instruments Corp. | PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM | 1988-07-08 | 14 |
| K831959 | Kent Laboratories, Inc. | RADIAL IMMUNO-TEST FOR HUMAN FACTOR B | 1983-07-19 | 32 |
| K811740 | Kallestad Laboratories, Inc. | KALLESTAD'S ENDOPLATE FACTOR B TEST | 1981-07-16 | 27 |
| K781016 | Icl Scientific | C3PA (GBG) PROPERDIN FACTOR B | 1978-08-14 | 59 |
Recalls for JZH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-10-16.
Frequently asked questions
What is FDA product code JZH?
JZH is the FDA product code for factor b, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5320 and reviewed by the Immunology panel.
What device class is JZH?
Class II, regulation 21 CFR 866.5320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZH?
Across 6 cleared submissions the average was 51 days from receipt to decision (median 46).
Which companies have the most JZH clearances?
Beckman Instruments, Inc. (1); Technicon Instruments Corp. (1); Kent Laboratories, Inc. (1); Kallestad Laboratories, Inc. (1); Icl Scientific (1).
Have JZH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-10-16.
Next steps
- Run an FDA pathway report with predicate devices for product code JZH
- Run a recall and safety report across every JZH manufacturer
- Watch product code JZH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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