510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110274Substantially Equivalent

Autodelfia Neonatal Irt Kit

Wallac Oy, A Subsidiary of Perkinelmer, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110274 is the FDA 510(k) clearance record for AUTODELFIA NEONATAL IRT KIT, a class I device, cleared for Wallac Oy, A Subsidiary of Perkinelmer, Inc. on under FDA product code JNO (N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin). FDA records list 4 510(k) clearances for Wallac Oy, A Subsidiary of Perkinelmer, Inc., from to . As of , FDA records show one recall naming K110274.

Clearance record

Decision date
Received
(130 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
Wallac Oy, A Subsidiary of Perkinelmer, Inc. 940 Winter St., Waltham MA
510(k) summary
Summary PDF
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