ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
FDA 510(k) clearance K042118 · decided 2005-04-29
Clearance details
- K-number
- K042118
- Device name
- ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-06
- Decision date
- 2005-04-29
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- JRY
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. (K900974) | Stellar Bio Systems, Inc. | 1990-04-16 |
| BION EBV-G (VCA) TEST SYSTEM (K891785) | Bion Ent., Ltd. | 1989-08-31 |
| EBV EARLY ANTIGEN (R+D) (K884829) | Hillcrest Biologicals | 1989-04-12 |
| EBV IGM TEST (K822734) | Gull Laboratories, Inc. | 1982-12-09 |
| EBV-M KIT (K822985) | Litton Bionetics | 1982-12-03 |
| EBV-VCA ANTIBODY ASSAY KIT (K821849) | Biotech Research Laboratories, Inc. | 1982-08-12 |
| EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI (K811262) | Zeus Scientific, Inc. | 1981-05-27 |
| EB-VCA, TEST, ANTIBODY, FLUORESCENT (K780925) | Litton Bionetics | 1978-06-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042) | Zeus Scientific, Inc. | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045) | Zeus Scientific, Inc. | 2017-09-19 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S001) | Zeus Scientific, Inc. | 1992-04-21 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S002) | Zeus Scientific, Inc. | 1992-04-17 |
| FLUORO-CEP (R) PROGESTERONE (P900025) | Zeus Scientific, Inc. | 1990-09-26 |