510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961515Substantially Equivalent

Quantase Phenylalanine Assay

Shield Diagnostics, Ltd., Dundee, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961515 is the FDA 510(k) clearance record for QUANTASE PHENYLALANINE ASSAY, a class II device, cleared for Shield Diagnostics, Ltd. on under FDA product code JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine). FDA records list 27 510(k) clearances for Shield Diagnostics, Ltd., from to . As of , FDA records show one recall naming K961515.

Clearance record

Decision date
Received
(63 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
Shield Diagnostics, Ltd. The Technology Park, Dundee, 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