THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
FDA 510(k) clearance K984133 · decided 1999-01-11
Clearance details
- K-number
- K984133
- Device name
- THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-18
- Decision date
- 1999-01-11
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- LLM
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zeus Scientific
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS (K040120) | DiaSorin, Inc. | 2005-04-29 |
| 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.
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 |