510(k) K042118
- Device
- ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- 510(k) number
- K042118
- Product code
- JRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-04-29
- Date received
- 2004-08-06
- Regulation
- 866.3235
- Classification name
- Antiserum, Fluorescent, Epstein-Barr Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARK J KOPNITSKY
- Address
- 200 Evans Way Branchburg NJ US 08876 08876
FDA Registration Numbers#
- 2029372
- 1419968
- 3004973408
- 2242436
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JRY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | Stellar Bio Systems, Inc. | 1990-04-16 |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | Bion Ent., Ltd. | 1989-08-31 |
| K884829 | EBV EARLY ANTIGEN (R+D) | Hillcrest Biologicals | 1989-04-12 |
| K822734 | EBV IGM TEST | Gull Laboratories, Inc. | 1982-12-09 |
| K822985 | EBV-M KIT | Litton Bionetics | 1982-12-03 |
| K821849 | EBV-VCA ANTIBODY ASSAY KIT | Biotech Research Laboratories, Inc. | 1982-08-12 |
| K811262 | EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI | Zeus Scientific, Inc. | 1981-05-27 |
| K780925 | EB-VCA, TEST, ANTIBODY, FLUORESCENT | Litton Bionetics | 1978-06-22 |