510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963040Substantially Equivalent

Manual Phenylalanine Test

Bio-Rad, Hercules CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963040 is the FDA 510(k) clearance record for MANUAL PHENYLALANINE TEST, a class II device, cleared for Bio-Rad on under FDA product code JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K963040.

Clearance record

Decision date
Received
(57 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
Bio-Rad 4000 Alfred Nobel Dr., Hercules CA
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