510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190661Substantially Equivalent

Omics Core

Nanthealth, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190661 is the FDA 510(k) clearance record for Omics Core, a class II device, cleared for Nanthealth, Inc. on under FDA product code PZM (Next Generation Sequencing Based Tumor Profiling Test). FDA's definition for product code PZM reads: "A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens...". FDA records list one 510(k) clearance for Nanthealth, Inc. As of , FDA records show no recalls naming K190661.

Clearance record

Decision date
Received
(240 days to decision)
Product code
PZM Next Generation Sequencing Based Tumor Profiling Test
Regulation
21 CFR 866.6080
Device class
Class II
Review panel
Pathology
Applicant
Nanthealth, Inc. 9920 Jefferson Blvd., Culver City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZM

Trailing 12 months
1 clearance under product code PZM in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PZM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260