510(k) K844589

OSMOLARITY STANDARDS by Rna Medical Corp. — Product Code JMZ

K844589 is an FDA 510(k) premarket notification submitted by Rna Medical Corp. for the device "OSMOLARITY STANDARDS". The FDA issued a decision of Substantially Equivalent on March 1, 1985. The device falls under product code JMZ (Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality), a Class I device regulated under 21 CFR 862.1540. Rna Medical Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1985
Date Received
November 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Device Class
Class I
Regulation Number
862.1540
Review Panel
CH
Submission Type