510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K872197Substantially Equivalent

Procedure No. 552/553 Bilirubin, Total and Direct

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

K872197 is the FDA 510(k) clearance record for PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K872197.

Clearance record

Decision date
Received
(66 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
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 CIG

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