510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812288Substantially Equivalent

Human C-Peptide Reagents

Immunex Radiochemical Diagnostics, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812288 is the FDA 510(k) clearance record for HUMAN C-PEPTIDE REAGENTS, a class I device, cleared for Immunex Radiochemical Diagnostics on under FDA product code JKD (Radioimmunoassay, C-Peptides Of Proinsulin). FDA records list one 510(k) clearance for Immunex Radiochemical Diagnostics. As of , FDA records show no recalls naming K812288.

Clearance record

Decision date
Received
(18 days to decision)
Product code
JKD Radioimmunoassay, C-Peptides Of Proinsulin
Regulation
21 CFR 862.1135
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Immunex Radiochemical Diagnostics 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JKD

Trailing 12 months

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

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