ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
FDA 510(k) clearance K042092 · decided 2005-04-12
Clearance details
- K-number
- K042092
- Device name
- ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-03
- Decision date
- 2005-04-12
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- LJN
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Raritan, 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 |
|---|---|---|
| BIOPLEX 2200 EBV IGM KIT (K123021) | Bio-Rad Laboratories | 2012-11-02 |
| PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M (K073381) | Focus Diagnostics, Inc. | 2008-08-04 |
| MODIFICATION TO SERAQUEST VCA IGM (K033780) | Quest Intl., Inc. | 2004-01-15 |
| SERAQUEST EB VAC IGM (K990977) | Quest Intl., Inc. | 1999-10-06 |
| COPALIS EBV-M ANTIBODY ASSAY (K991459) | DiaSorin, Inc. | 1999-05-14 |
| IMMUNOWELL VCA IGM TEST (K973939) | Genbio | 1998-08-10 |
| EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY (K931520) | Mrl Diagnostics | 1994-04-26 |
| ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA (K930020) | Ortho Diagnostic Systems, Inc. | 1993-07-16 |
| BARTELS EPSTEIN-BARR VIRUS IGM EIA (K922331) | Baxter Diagnostics, Inc. | 1992-09-02 |
| EBV-VCA IGM ELISA (K915348) | Pharmacia Diagnostics, Inc. | 1992-02-14 |
| AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST (K911362) | Amico Laboratories, Inc. | 1991-10-07 |
| EBV IGM ELISA TEST (K910042) | Gull Laboratories, Inc. | 1991-02-21 |
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 |