FDA product code JZS: Electrophoresis Instrumentation
JZS is the FDA product code for electrophoresis instrumentation. It is a Class I device, regulated under 21 CFR 866.4500 and reviewed by the Immunology panel. FDA has cleared 6 510(k) submissions under JZS, from 4 different applicants. The average 510(k) review took 24 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Electrophoresis Instrumentation |
| Device class | Class I |
| Regulation | 21 CFR 866.4500 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZS clearance
Top JZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kallestad Laboratories, Inc. | 3 | 1977-04-27 |
| Elias U.S.A., Inc. | 1 | 1993-08-23 |
| American Scientific Products | 1 | 1981-08-31 |
| Millipore Corp. | 1 | 1977-02-01 |
Most recent JZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933123 | Elias U.S.A., Inc. | SYNELISA TG ANTIBODIES/TPO ANTIBODIES | 1993-08-23 | 56 |
| K812194 | American Scientific Products | IMMUNODIFFUSION BAND INTENSIFYING FLUID | 1981-08-31 | 28 |
| K770566 | Kallestad Laboratories, Inc. | IMMUNOELECTROPHORESIS PROFILE KIT | 1977-04-27 | 34 |
| K770718 | Kallestad Laboratories, Inc. | STAIN, R-250, COOMASSIE BRILLIANT BLUE | 1977-04-26 | 8 |
| K770719 | Kallestad Laboratories, Inc. | IMMUNOELECTROFILM KIH | 1977-04-26 | 8 |
Recalls for JZS devices
openFDA lists no recalls for product code JZS.
Frequently asked questions
What is FDA product code JZS?
JZS is the FDA product code for electrophoresis instrumentation. It is a Class I device, regulated under 21 CFR 866.4500 and reviewed by the Immunology panel.
What device class is JZS?
Class I, regulation 21 CFR 866.4500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZS?
Across 6 cleared submissions the average was 24 days from receipt to decision (median 18).
Which companies have the most JZS clearances?
Kallestad Laboratories, Inc. (3); Elias U.S.A., Inc. (1); American Scientific Products (1); Millipore Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JZS
- Run a recall and safety report across every JZS manufacturer
- Watch product code JZS 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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