510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K983420Substantially Equivalent

The Aptus(automated)application of the Sm Elisa Test System.an Enzyme Link Immunosorbent Assay(elisa)for the Detectioo

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

K983420 is the FDA 510(k) clearance record for THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO, a class II device, cleared for Zeus Scientific, Inc. on under FDA product code LKP (Anti-Sm 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 K983420.

Clearance record

Decision date
Received
(50 days to decision)
Product code
LKP Anti-Sm Antibody, Antigen And Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Zeus Scientific, Inc. 200 Evans Way, Branchburg NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LKP

Trailing 12 months

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

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