510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984463Substantially Equivalent

Quantase Phe/gal Screening Assay

Quantase, Ltd., Perth, Scotland, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984463 is the FDA 510(k) clearance record for QUANTASE PHE/GAL SCREENING ASSAY, a class II device, cleared for Quantase , Ltd. on under FDA product code JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine). FDA records list 4 510(k) clearances for Quantase , Ltd., from to . As of , FDA records show no recalls naming K984463.

Clearance record

Decision date
Received
(62 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
Quantase , Ltd. 3 Riverview Business Park, Perth, Scotland, GB
510(k) summary
Statement
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