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

Test, Cystatin C

21 CFR 862.1225 / Clinical Chemistry
FDA source (opens on fda.gov)

NDY is the FDA product code for Test, Cystatin C, a class II device type, regulated under 21 CFR 862.1225. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
NDY
Device name
Test, Cystatin C
Regulation
21 CFR 862.1225
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
22
Ingested recalls
4

Clearances, product code NDY

By decision year
22 clearances under product code NDY with a decision year between 2001 and 2025, 2008 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code NDY by decision year
YearClearances
20011
20042
20073
20086
20091
20103
20121
20141
20161
20171
20181
20251

Applicants with the most clearances

Product code NDY
Applicants holding the most 510(k) clearances under product code NDY
ApplicantClearances
Siemens Healthcare Diagnostics Inc.5
Diazyme Laboratories, Inc.3
Gentian AS2
Roche Diagnostics GmbH2
The Binding Site2
Dako A/S1
Genzyme Corporation1
Kamiya Biomedical Company, LLC1
Roche Diagnostics Operations (Rdo)1
Sentinel CH SpA1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order