510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992800Substantially Equivalent

Sigma Diagnostics Infinity Bun Reagent, Models 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

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

K992800 is the FDA 510(k) clearance record for SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K992800.

Clearance record

Decision date
Received
(40 days to decision)
Product code
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sigma Diagnostics, Inc. 545 S. Ewing Ave., St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code CDQ

Trailing 12 months

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

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