510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K081875Substantially Equivalent

Gentian Cystatin C Immunoassay

Gentian AS, San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081875 is the FDA 510(k) clearance record for GENTIAN CYSTATIN C IMMUNOASSAY, a class II device, cleared for Gentian AS on under FDA product code NDY (Test, Cystatin C). FDA records list 2 510(k) clearances for Gentian AS, from to . As of , FDA records show one recall naming K081875.

Clearance record

Decision date
Received
(49 days to decision)
Product code
NDY Test, Cystatin C
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Gentian AS 9915 Cam, Chirimolla, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDY

Trailing 12 months

FDA records hold no clearances under product code NDY in the trailing twelve months.

FDA records show no clearances under product code NDY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NDY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260