ClearanceBrief
Panels › Clinical Chemistry › Product code KHS · Class 2

Enzymatic, Carbon-Dioxide

Regulation 862.1160

0510(k)s in 12 months (86 all time)
1recalls in 12 months (7 all time)
7recalls that name a 510(k)
Get daily alerts for KHSSample briefCSV

Top companies in KHS

DateFirm and productCodeLinked 510(k)
Dec 23, 2025Beckman Coulter Ireland, Inc.
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU anal
Open, Classified
KHSK131546
Dec 7, 2023Ortho-Clinical Diagnostics, INc.
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using
Open, Classified
KHSK182072
May 18, 2023Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Open, Classified
KHSK131546
May 18, 2023Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
Open, Classified
KHSK131546
May 18, 2023Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Open, Classified
KHSK131546
Oct 23, 2019Abbott GmBH & Co. KG
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Terminated
KHSK060295
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VI
Terminated
KHSK001133
K120765

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.