510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801346Substantially Equivalent

Nsi Reagent System for Ortho Elt-8 Hema

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

K801346 is the FDA 510(k) clearance record for NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA, a class I device, cleared for Nobel Scientific Industries, Inc. on under FDA product code GIF (Diluent, Blood Cell). FDA records list 23 510(k) clearances for Nobel Scientific Industries, Inc., from to . As of , FDA records show no recalls naming K801346.

Clearance record

Decision date
Received
(64 days to decision)
Product code
GIF Diluent, Blood Cell
Regulation
21 CFR 864.8200
Device class
Class I
Review panel
Hematology
Applicant
Nobel Scientific Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GIF

Trailing 12 months

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

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