The following data is part of a premarket notification filed by Rna Medical Corp. with the FDA for Standard Solution Of Conductivity & Measurement Of.
| Device ID | K851362 |
| 510k Number | K851362 |
| Device Name: | STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF |
| Classification | Solution-test Standard-conductivity, Dialysis |
| Applicant | RNA MEDICAL CORP. 21 CUMMINGS PARK SUITE 228 Woburn, MA 01801 |
| Contact | Adolph E D'amico |
| Correspondent | Adolph E D'amico RNA MEDICAL CORP. 21 CUMMINGS PARK SUITE 228 Woburn, MA 01801 |
| Product Code | FKH |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-04 |
| Decision Date | 1985-06-12 |