510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860138Substantially Equivalent

No. 615 Determination of Ceruloplasmin in Serum

Sigma Diagnostics, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860138 is the FDA 510(k) clearance record for NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code DDB (Ceruloplasmin, Antigen, Antiserum, Control). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K860138.

Clearance record

Decision date
Received
(73 days to decision)
Product code
DDB Ceruloplasmin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5210
Device class
Class II
Review panel
Immunology
Applicant
Sigma Diagnostics, Inc. P.O. Box 14508, St. Louis MO
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