510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K983465Substantially Equivalent

The Aptus (Automated) Application of the Sm/rnp Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the

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

K983465 is the FDA 510(k) clearance record for THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE, a class II device, cleared for Zeus Scientific, Inc. on under FDA product code LKO (Anti-Rnp Antibody, Antigen And Control). FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show no recalls naming K983465.

Clearance record

Decision date
Received
(48 days to decision)
Product code
LKO Anti-Rnp Antibody, Antigen And Control
Regulation
21 CFR 866.5100
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 LKO

Trailing 12 months

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

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