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

Cyclosporine

21 CFR 862.1235 / Clinical Chemistry
FDA source (opens on fda.gov)

MKW is the FDA product code for Cyclosporine, a class II device type, regulated under 21 CFR 862.1235. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
MKW
Device name
Cyclosporine
Regulation
21 CFR 862.1235
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
9
Ingested recalls
5

Clearances, product code MKW

By decision year
9 clearances under product code MKW with a decision year between 2002 and 2008, 2008 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MKW by decision year
YearClearances
20022
20041
20051
20062
20083

Applicants with the most clearances

Product code MKW
Applicants holding the most 510(k) clearances under product code MKW
ApplicantClearances
Siemens Healthcare Diagnostics Inc.6
Abbott Medical1
Fujirebio Diagnostics, Inc.1
Microgenics Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code