Zeus Scientific, Inc.

How does FDA spell Zeus Scientific, Inc.?

FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Zeus Scientific, Inc. file in?

48 product codes, ranked by how much they file in each.

Showing the 25 they file in most, of 48.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Zeus Scientific, Inc. had a recall?

openFDA lists 12 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

• Z-0602-2024Class IIOpen, ClassifiedMYL31 October 2023

  The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.

• Z-0603-2024Class IIOpen, ClassifiedMYL31 October 2023

  The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.

• Z-3026-2020Class IITerminatedMYM12 August 2019

  FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.

• Z-2494-2019Class IITerminated22 July 2019

  Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6.

• Z-1500-2012TerminatedLJY8 March 2012

  Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against Mumps.

Showing the 5 most recently initiated of 12.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Zeus Scientific, Inc. cleared recently?

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Where is Zeus Scientific, Inc. registered?

FDA lists 1 registered establishment for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.