510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760619Substantially Equivalent

Radio Immuno Assay Kit/

New England Nuclear, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760619 is the FDA 510(k) clearance record for RADIO IMMUNO ASSAY KIT/, a class II device, cleared for New England Nuclear on under FDA product code CDD (Radioassay, Vitamin B12). FDA records list 18 510(k) clearances for New England Nuclear, from to . As of , FDA records show no recalls naming K760619.

Clearance record

Decision date
Received
(84 days to decision)
Product code
CDD Radioassay, Vitamin B12
Regulation
21 CFR 862.1810
Device class
Class II
Review panel
Clinical Chemistry
Applicant
New England Nuclear 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CDD

Trailing 12 months

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

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