510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844589Substantially Equivalent

Osmolarity Standards

Rna Medical Corp., Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844589 is the FDA 510(k) clearance record for OSMOLARITY STANDARDS, a class I device, cleared for Rna Medical Corp. on under FDA product code JMZ (Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality). FDA records list 6 510(k) clearances for Rna Medical Corp., from to . As of , FDA records show no recalls naming K844589.

Clearance record

Decision date
Received
(95 days to decision)
Product code
JMZ Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Regulation
21 CFR 862.1540
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Rna Medical Corp. 21 Cummings Park, Woburn MA
Third party review
No

Clearances, product code JMZ

Trailing 12 months

FDA records hold no clearances under product code JMZ in the trailing twelve months.

FDA records show no clearances under product code JMZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JMZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260