510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880039Substantially Equivalent

Ammonia Controls Low and High #a 5565 & a 6665

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

K880039 is the FDA 510(k) clearance record for AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665, a class I device, cleared for Sigma Diagnostics, Inc. on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K880039.

Clearance record

Decision date
Received
(50 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sigma Diagnostics, Inc. P.O. Box 14508, St. Louis MO
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

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