510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932406Substantially Equivalent

Nuclitryp(tm)(i125)-Human Pancrea Cath Try Rad Kit

Nuclear Diagnostics, Inc., Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932406 is the FDA 510(k) clearance record for NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT, a class I device, cleared for Nuclear Diagnostics, Inc. on under FDA product code JNO (N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin). FDA records list 24 510(k) clearances for Nuclear Diagnostics, Inc., from to . As of , FDA records show no recalls naming K932406.

Clearance record

Decision date
Received
(203 days to decision)
Product code
JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Regulation
21 CFR 862.1725
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Nuclear Diagnostics, Inc. 3322 Commercial Ave., Northbrook IL
510(k) summary
Statement
Third party review
No

Clearances, product code JNO

Trailing 12 months

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

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