510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830843Substantially Equivalent

Blood Gas Solutions & Co-Oximeter Solu-

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

K830843 is the FDA 510(k) clearance record for BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-, a class I device, cleared for Rna Medical Corp. on under FDA product code JKT (Gas Chromatograph, Carbon-Monoxide). FDA records list 6 510(k) clearances for Rna Medical Corp., from to . As of , FDA records show no recalls naming K830843.

Clearance record

Decision date
Received
(42 days to decision)
Product code
JKT Gas Chromatograph, Carbon-Monoxide
Regulation
21 CFR 862.3220
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Rna Medical Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JKT

Trailing 12 months

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

FDA records show no clearances under product code JKT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JKT, 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