The following data is part of a premarket notification filed by American Scientific Products with the FDA for Immunodiffusion Band Intensifying Fluid.
| Device ID | K812194 |
| 510k Number | K812194 |
| Device Name: | IMMUNODIFFUSION BAND INTENSIFYING FLUID |
| Classification | Electrophoresis Instrumentation |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JZS |
| CFR Regulation Number | 866.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-03 |
| Decision Date | 1981-08-31 |