510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K961277Substantially Equivalent

RF Igm Elisa Test System

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

K961277 is the FDA 510(k) clearance record for RF IGM ELISA TEST SYSTEM, a class II device, cleared for Zeus Scientific, Inc. on under FDA product code DHR (System, Test, Rheumatoid Factor). FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show one recall naming K961277.

Clearance record

Decision date
Received
(35 days to decision)
Product code
DHR System, Test, Rheumatoid Factor
Regulation
21 CFR 866.5775
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 DHR

Trailing 12 months

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

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