ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
FDA 510(k) clearance K951851 · decided 1996-07-24
Clearance details
- K-number
- K951851
- Device name
- ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-21
- Decision date
- 1996-07-24
- Days to decision
- 460 days
- Clearance type
- Traditional
- Product code
- LJO
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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| CMVGEN (K974456) | Instrumentation Laboratory CO | 1998-05-01 |
| COPALIS CMV TOTAL ANTIBODY ASSAY (K955799) | Sienna Biotech, Inc. | 1996-07-10 |
| HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS (K920222) | Akers Research Corp. | 1992-07-27 |
| CYTOMEGALOVIRUS ANTIBODY SCREEN (K910003) | Immucor, Inc. | 1991-03-20 |
| CMV-IHA (K852494) | Hillcrest Biologicals | 1985-09-16 |
| CMV LATEX AGGLUTINATION TEST KIT (K841520) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-09-07 |
| CETUS CMV IHA (K822965) | Cetus Corp. | 1983-02-15 |
Recalls involving this device
No recalls on record reference this clearance.