510(k) K984133
- Device
- THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- Applicant
- ZEUS SCIENTIFIC, INC.
- 510(k) number
- K984133
- Product code
- LLM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-01-11
- Date received
- 1998-11-18
- Regulation
- 866.3235
- Classification name
- Test, Antigen, Nuclear, Epstein-barr Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK J KOPNITSKY
- Address
- 200 Evans Way Branchburg NJ US 08876 08876
FDA Registration Numbers#
- 3004036192
- 2918768
- 9610240
- 1318354
- 9610746
- 2242436
- 2029372
- 1419968
- 3022178699
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LLM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233605 | ADVIA Centaur EBV-EBNA IgG | Biokit, S.A. | 2024-08-07 |
| K040120 | DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS | DiaSorin, Inc. | 2005-04-29 |
| K973941 | IMMUNOWELL EBNA IGG TEST | Genbio | 1998-08-10 |
| K980598 | EBNA-1 IGM ELISA TEST SYSTEM | Clark Laboratories, Inc. | 1998-05-01 |
| K951549 | EBNA IGG EIA TEST SYSTEM | Immunoprobe, Inc. | 1996-04-29 |
| K951822 | EBNA ENZYME IMMUNOASSAY KIT | Granbio, Inc. | 1996-02-15 |
| K935730 | EBNA IGG ELISA TEST | Gull Laboratories, Inc. | 1995-09-19 |
| K946353 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY | Mrl Diagnostics | 1995-07-21 |
| K946158 | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT | Incstar Corp. | 1995-06-09 |
| K932742 | EBNA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1995-05-05 |
| K925690 | MERIDIAN EBNA TEST KIT | Fuller Laboratories, Inc. | 1993-10-12 |
| K930002 | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | 1993-07-16 |
| K911473 | EBNA STAT TEST KIT | Whittaker Bioproducts, Inc. | 1991-09-25 |
| K911569 | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1991-06-10 |
| K895708 | EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) | Immuno Concepts, Inc. | 1989-12-11 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases