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

Titrimetric With Edta And Indicator, Calcium

21 CFR 862.1145 / Clinical Chemistry
FDA source (opens on fda.gov)

CHW is the FDA product code for Titrimetric With Edta And Indicator, Calcium, a class II device type, regulated under 21 CFR 862.1145. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CHW
Device name
Titrimetric With Edta And Indicator, Calcium
Regulation
21 CFR 862.1145
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
3
Ingested recalls
0

Clearances, product code CHW

By decision year
3 clearances under product code CHW with a decision year between 1978 and 2020, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CHW by decision year
YearClearances
19781
20121
20201

Applicants with the most clearances

Product code CHW
Applicants holding the most 510(k) clearances under product code CHW
ApplicantClearances
Biosystems S.A.1
Roche Diagnostics GmbH1
Union Carbide Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code