510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011596Substantially Equivalent

Urea Nitrogen (Bun) Liquid Reagent

Jas Diagnostic, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011596 is the FDA 510(k) clearance record for UREA NITROGEN (BUN) LIQUID REAGENT, a class II device, cleared for Jas Diagnostic, Inc. on under FDA product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen). FDA records list one 510(k) clearance for Jas Diagnostic, Inc. As of , FDA records show no recalls naming K011596.

Clearance record

Decision date
Received
(54 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
Jas Diagnostic, Inc. 7220 NW 58th St., Miami FL
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