510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926320Substantially Equivalent

Reflab System Pack Liquid CO2 Reagent

Medical Analysis Systems, Inc., Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926320 is the FDA 510(k) clearance record for REFLAB SYSTEM PACK LIQUID CO2 REAGENT, a class II device, cleared for Medical Analysis Systems, Inc. on under FDA product code CHS (Coulometric Method, Carbon-Dioxide). FDA records list 107 510(k) clearances for Medical Analysis Systems, Inc., from to . As of , FDA records show no recalls naming K926320.

Clearance record

Decision date
Received
(50 days to decision)
Product code
CHS Coulometric Method, Carbon-Dioxide
Regulation
21 CFR 862.1160
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Medical Analysis Systems, Inc. Lincoln Technology Park, Camarillo CA
510(k) summary
Summary
Third party review
No

Clearances, product code CHS

Trailing 12 months

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

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