The following data is part of a premarket notification filed by Rna Medical Corp. with the FDA for Osmolarity Standards.
| Device ID | K844589 |
| 510k Number | K844589 |
| Device Name: | OSMOLARITY STANDARDS |
| Classification | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality |
| 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 | JMZ |
| CFR Regulation Number | 862.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-26 |
| Decision Date | 1985-03-01 |