TEST, MONO., CARD (MACRO-VUE)
FDA 510(k) clearance K760040 · decided 1976-08-03
Clearance details
- K-number
- K760040
- Device name
- TEST, MONO., CARD (MACRO-VUE)
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1976-06-15
- Decision date
- 1976-08-03
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- KTN
- Device class
- 2
- Regulation number
- 866.5640
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Washington, DC, 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 |
|---|---|---|
| OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test (K181436) | SEKISUI Diagnostics, LLC | 2018-06-22 |
| ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (K042272) | ACON Laboratories, Inc. | 2005-02-28 |
| BIORAPID MONONUCLEOSIS (K030215) | Instrumentation Laboratory CO | 2003-02-24 |
| COLOR-MONOGEN (K012901) | Instrumentation Laboratory CO | 2001-09-27 |
| DRYSPOT INFECTIOUS MONONUCLEOSIS KIT (K982634) | Oxoid , Ltd. | 1999-01-28 |
| CLEARVIEW IM (K981946) | Unipath , Ltd. | 1998-12-10 |
| MONOCOL/LEX-IM TEST (K972457) | Immunostics Inc., | 1997-12-01 |
| OSOM MONO TEST 143 (K972231) | Wyntek Diagnostics, Inc. | 1997-08-26 |
| GENZYME DIAGNOSTICS CONTRAST MONO (K963425) | Genzyme Diagnostics | 1997-02-25 |
| BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (K961024) | Princeton BioMeditech Corp. | 1997-02-04 |
| QUALITROL MONO CONTROL SERUM SET (K961550) | Consolidated Technologies, Inc. | 1996-09-24 |
| IMMUNOCARD MONO (K930778) | Meridian Diagnostics, Inc. | 1993-12-27 |
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 |