The following data is part of a premarket notification filed by Sartorius Filters, Inc. with the FDA for Cellulose Acetate Membrane Strips.
| Device ID | K822285 |
| 510k Number | K822285 |
| Device Name: | CELLULOSE ACETATE MEMBRANE STRIPS |
| Classification | Apparatus, Electrophoresis, For Clinical Use |
| Applicant | SARTORIUS FILTERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJN |
| CFR Regulation Number | 862.2485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-30 |
| Decision Date | 1982-09-21 |