510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950920Substantially Equivalent

Dupont Dimension Total Protein Method

Dupont Medical Products, Wilmington DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950920 is the FDA 510(k) clearance record for DUPONT DIMENSION TOTAL PROTEIN METHOD, a class II device, cleared for Dupont Medical Products on under FDA product code CEK (Biuret (Colorimetric), Total Protein). FDA records list 28 510(k) clearances for Dupont Medical Products, from to . As of , FDA records show no recalls naming K950920.

Clearance record

Decision date
Received
(163 days to decision)
Product code
CEK Biuret (Colorimetric), Total Protein
Regulation
21 CFR 862.1635
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dupont Medical Products P.O. Box 80022, Bmp 22-1174, Wilmington DE
510(k) summary
Summary
Third party review
No

Clearances, product code CEK

Trailing 12 months

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

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