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
K984315Substantially Equivalent

The Aptus (Automated) Application of the Pr-3 Elisa Test System. an Aneyme Linked Immunosorbent Assay (Elisa) for the De

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

K984315 is the FDA 510(k) clearance record for THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE, a class II device, cleared for Zeus Scientific, Inc. on under FDA product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)). FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show no recalls naming K984315.

Clearance record

Decision date
Received
(14 days to decision)
Product code
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Regulation
21 CFR 866.5660
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 MOB

Trailing 12 months
1 clearance under product code MOB in the twelve months to November 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MOB, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260