510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823107Substantially Equivalent

Quantimetric 2 Ceruloplasmin Assay

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

K823107 is the FDA 510(k) clearance record for QUANTIMETRIC 2 CERULOPLASMIN ASSAY, a class II device, cleared for Kallestad Laboratories, Inc. on under FDA product code DDB (Ceruloplasmin, Antigen, Antiserum, Control). FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K823107.

Clearance record

Decision date
Received
(26 days to decision)
Product code
DDB Ceruloplasmin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5210
Device class
Class II
Review panel
Immunology
Applicant
Kallestad Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DDB

Trailing 12 months

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

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