The following data is part of a premarket notification filed by Icl Scientific with the FDA for Kova Strip 6.
| Device ID | K811219 |
| 510k Number | K811219 |
| Device Name: | KOVA STRIP 6 |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-04 |
| Decision Date | 1981-05-21 |