510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K802518Substantially Equivalent

Bun Reagent Astra 4 & 8 Analyzers

Nobel Scientific Industries, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802518 is the FDA 510(k) clearance record for BUN REAGENT ASTRA 4 & 8 ANALYZERS, a class II device, cleared for Nobel Scientific Industries, Inc. on under FDA product code CDN (Urease, Photometric, Urea Nitrogen). FDA records list 23 510(k) clearances for Nobel Scientific Industries, Inc., from to . As of , FDA records show no recalls naming K802518.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CDN Urease, Photometric, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Nobel Scientific Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CDN

Trailing 12 months

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

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