510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020823Substantially Equivalent

Peliclass Human Igg Subclass Nephelometric Immage Kit

Sanquin Blood Supply Foundation, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020823 is the FDA 510(k) clearance record for PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT, a class II device, cleared for Sanquin Blood Supply Foundation on under FDA product code DFZ (Igg (Gamma Chain Specific), Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Sanquin Blood Supply Foundation. As of , FDA records show no recalls naming K020823.

Clearance record

Decision date
Received
(61 days to decision)
Product code
DFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Sanquin Blood Supply Foundation 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DFZ

Trailing 12 months

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

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