HYBRID CAPTURE SYSTEM CMV DNA ASSAY
FDA 510(k) clearance K974901 · decided 1998-09-29
Clearance details
- K-number
- K974901
- Device name
- HYBRID CAPTURE SYSTEM CMV DNA ASSAY
- Applicant
- Digene Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-31
- Decision date
- 1998-09-29
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- LJO
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Beltsville, MD, 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 |
|---|---|---|
| Capture-CMV (K203612) | Immucor, Inc. | 2021-03-22 |
| Capture-CMV (K183571) | Immucor, Inc. | 2019-02-04 |
| DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM (K001767) | Diamedix Corp. | 2000-08-07 |
| CMVGEN (K974456) | Instrumentation Laboratory CO | 1998-05-01 |
| ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY (K951851) | E.I. Dupont DE Nemours & Co., Inc. | 1996-07-24 |
| 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.