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
K992188Substantially Equivalent

Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model 62-7028

Nichols Institute Diagnostics, San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992188 is the FDA 510(k) clearance record for NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028, a class II device, cleared for Nichols Institute Diagnostics on under FDA product code JNM (Immunochemical, Transferrin). FDA records list 68 510(k) clearances for Nichols Institute Diagnostics, from to . As of , FDA records show no recalls naming K992188.

Clearance record

Decision date
Received
(160 days to decision)
Product code
JNM Immunochemical, Transferrin
Regulation
21 CFR 866.5880
Device class
Class II
Review panel
Immunology
Applicant
Nichols Institute Diagnostics 33051 Calle Aviador, San Juan Capistrano CA
510(k) summary
Summary
Third party review
No

Clearances, product code JNM

Trailing 12 months

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

FDA records show no clearances under product code JNM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JNM, 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