510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K924197Substantially Equivalent

Zorba(tm) Igg Removal Reagent

Zeus Scientific LLC, Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924197 is the FDA 510(k) clearance record for ZORBA(TM) IGG REMOVAL REAGENT, a class II device, cleared for Zeus Scientific, Inc. on under FDA product code DEW (Igg, Antigen, Antiserum, Control). FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show no recalls naming K924197.

Clearance record

Decision date
Received
(117 days to decision)
Product code
DEW Igg, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Zeus Scientific, Inc. P.O.Box 38, Raritan NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DEW

Trailing 12 months

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

FDA records show no clearances under product code DEW in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DEW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260