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

Cytokeratin Fragments 21-1 Eia Kit

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

OVK is the FDA product code for Cytokeratin Fragments 21-1 Eia Kit, a class II device type, regulated under 21 CFR 866.6010. FDA's definition for this code reads: "The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OVK
Device name
Cytokeratin Fragments 21-1 Eia Kit
FDA definition
The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
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 OVK

By decision year
3 clearances under product code OVK with a decision year between 2011 and 2025, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OVK by decision year
YearClearances
20111
20161
20251

Applicants with the most clearances

Product code OVK
Applicants holding the most 510(k) clearances under product code OVK
ApplicantClearances
Fujirebio Diagnostics, Inc.2
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code