510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833396Substantially Equivalent

C-Peptide Radioimmunoassay Test Kit

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

K833396 is the FDA 510(k) clearance record for C-PEPTIDE RADIOIMMUNOASSAY TEST KIT, a class I device, cleared for Serono Diagnostics, Inc. on under FDA product code JKD (Radioimmunoassay, C-Peptides Of Proinsulin). FDA records list 25 510(k) clearances for Serono Diagnostics, Inc., from to . As of , FDA records show no recalls naming K833396.

Clearance record

Decision date
Received
(196 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
Serono Diagnostics, Inc. 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