510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900819Substantially Equivalent

Blood Gas Calibration Standard

Cryogenic Rare Gas Laboratories, Inc., Hanahan SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900819 is the FDA 510(k) clearance record for BLOOD GAS CALIBRATION STANDARD, a class I device, cleared for Cryogenic Rare Gas Laboratories, Inc. on under FDA product code LCH (Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical). FDA records list one 510(k) clearance for Cryogenic Rare Gas Laboratories, Inc. As of , FDA records show no recalls naming K900819.

Clearance record

Decision date
Received
(63 days to decision)
Product code
LCH Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Cryogenic Rare Gas Laboratories, Inc. 913 Commerce Cir., Hanahan SC
Third party review
No

Clearances, product code LCH

Trailing 12 months

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

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