510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200997Substantially Equivalent

Lumipulse G CA19-9-N

Fujirebio Diagnostics, Inc., Malvern PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200997 is the FDA 510(k) clearance record for Lumipulse G CA19-9-N, a class II device, cleared for Fujirebio Diagnostics,Inc. on under FDA product code NIG (System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer). FDA's definition for product code NIG reads: "An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma. The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial...". FDA records list 45 510(k) clearances for Fujirebio Diagnostics,Inc., from to . As of , FDA records show no recalls naming K200997.

Clearance record

Decision date
Received
(28 days to decision)
Product code
NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Fujirebio Diagnostics,Inc. 201 Great Valley Pkwy., Malvern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NIG

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