JZS
6 FDA 510(k) clearances · Product code
28 daysmedian time to decision
56 days90th percentile
6clearances measured
FDA profile
- Official device name
- Electrophoresis Instrumentation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4500
- Medical specialty
- Immunology
- Adverse events (MAUDE)
- 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SYNELISA TG ANTIBODIES/TPO ANTIBODIES (K933123) | Elias U.S.A., Inc. | 1993-08-23 |
| IMMUNODIFFUSION BAND INTENSIFYING FLUID (K812194) | American Scientific Products | 1981-08-31 |
| IMMUNOELECTROPHORESIS PROFILE KIT (K770566) | Kallestad Laboratories, Inc. | 1977-04-27 |
| STAIN, R-250, COOMASSIE BRILLIANT BLUE (K770718) | Kallestad Laboratories, Inc. | 1977-04-26 |
| IMMUNOELECTROFILM KIH (K770719) | Kallestad Laboratories, Inc. | 1977-04-26 |
| ELECTRO IMMUNO ASSAY KIT (K770150) | Millipore Corp. | 1977-02-01 |
Track JZS automatically
Every clearance here is in the API, with alerts when new ones post.