CMV LATEX AGGLUTINATION TEST KIT
FDA 510(k) clearance K841520 · decided 1984-09-07
Clearance details
- K-number
- K841520
- Device name
- CMV LATEX AGGLUTINATION TEST KIT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1984-04-12
- Decision date
- 1984-09-07
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- LJO
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bd Becton Dickinson Vacutainer Systems Preanalytic
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 |
|---|---|---|
| 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 |
| HYBRID CAPTURE SYSTEM CMV DNA ASSAY (K974901) | Digene Corp. | 1998-09-29 |
| 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 |
| CETUS CMV IHA (K822965) | Cetus Corp. | 1983-02-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |