DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
FDA 510(k) clearance K040120 · decided 2005-04-29
Clearance details
- K-number
- K040120
- Device name
- DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-20
- Decision date
- 2005-04-29
- Days to decision
- 465 days
- Clearance type
- Traditional
- Product code
- LLM
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Stillwater, MN, 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 |
|---|---|---|
| ADVIA Centaur EBV-EBNA IgG (K233605) | Biokit, S.A. | 2024-08-07 |
| THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH (K984133) | Zeus Scientific, Inc. | 1999-01-11 |
| IMMUNOWELL EBNA IGG TEST (K973941) | Genbio | 1998-08-10 |
| EBNA-1 IGM ELISA TEST SYSTEM (K980598) | Clark Laboratories, Inc. | 1998-05-01 |
| EBNA IGG EIA TEST SYSTEM (K951549) | Immunoprobe, Inc. | 1996-04-29 |
| EBNA ENZYME IMMUNOASSAY KIT (K951822) | Granbio, Inc. | 1996-02-15 |
| EBNA IGG ELISA TEST (K935730) | Gull Laboratories, Inc. | 1995-09-19 |
| EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (K946353) | Mrl Diagnostics | 1995-07-21 |
| INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (K946158) | Incstar Corp. | 1995-06-09 |
| EBNA IGG ELISA TEST SYSTEM (K932742) | Zeus Scientific, Inc. | 1995-05-05 |
| MERIDIAN EBNA TEST KIT (K925690) | Fuller Laboratories, Inc. | 1993-10-12 |
| ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA (K930002) | Ortho Diagnostic Systems, Inc. | 1993-07-16 |
Recalls involving this device
No recalls on record reference this clearance.