510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K861467Substantially Equivalent

Albumin (Bcg) Reagent

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

K861467 is the FDA 510(k) clearance record for ALBUMIN (BCG) REAGENT, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code CIX (Bromcresol Green Dye-Binding, Albumin). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K861467.

Clearance record

Decision date
Received
(32 days to decision)
Product code
CIX Bromcresol Green Dye-Binding, Albumin
Regulation
21 CFR 862.1035
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sigma Diagnostics, Inc. P.O. Box 14508, St. Louis MO
Third party review
No

Clearances, product code CIX

Trailing 12 months
1 clearance under product code CIX in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260