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

Coulometric Method, Carbon-Dioxide

21 CFR 862.1160 / Clinical Chemistry
FDA source (opens on fda.gov)

CHS is the FDA product code for Coulometric Method, Carbon-Dioxide, a class II device type, regulated under 21 CFR 862.1160. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CHS
Device name
Coulometric Method, Carbon-Dioxide
Regulation
21 CFR 862.1160
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code CHS

By decision year
6 clearances under product code CHS with a decision year between 1980 and 1993, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CHS by decision year
YearClearances
19801
19811
19841
19861
19911
19931

Applicants with the most clearances

Product code CHS
Applicants holding the most 510(k) clearances under product code CHS
ApplicantClearances
Amresco, Inc.1
Corning Medical & Scientific1
Eastman Kodak Company1
Medical Analysis Systems, Inc.1
Roche Diagnostic Systems, Inc.1
Technicon Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code CHS.