510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K021541Substantially Equivalent

Neogram Pku Tandem Mass Spectrometry Kit

Revvity Health Sciences, Inc., Norton OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021541 is the FDA 510(k) clearance record for NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT, a class II device, cleared for Perkinelmer Life Sciences on under FDA product code JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine). FDA records list 81 510(k) clearances for Revvity Health Sciences, Inc., from to . As of , FDA records show one recall naming K021541.

Clearance record

Decision date
Received
(171 days to decision)
Product code
JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Regulation
21 CFR 862.1555
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Perkinelmer Life Sciences 3985 Eastern Rd., Norton OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JNB

Trailing 12 months

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

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