BBL CAMPYSLIDE(TM) TEST
FDA 510(k) clearance K864027 · decided 1986-12-11
Clearance details
- K-number
- K864027
- Device name
- BBL CAMPYSLIDE(TM) TEST
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1986-10-15
- Decision date
- 1986-12-11
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- LQP
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Franklin Lakes, NJ, 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 |
|---|---|---|
| Curian Campy (K210976) | Meridian Bioscience, Inc. | 2021-12-23 |
| Sofia 2 Campylobacter FIA (K211342) | Quidel Corporation | 2021-11-23 |
| Campylobacter Chek (K191442) | Techlab, Inc. | 2019-06-20 |
| Campylobacter Quik Chek (K191456) | Techlab, Inc. | 2019-06-20 |
| CAMPYLOBACTER CHEK (K173219) | Techlab, Inc. | 2018-01-22 |
| CAMPYLOBACTER QUIK CHEK (K173217) | Techlab, Inc. | 2018-01-22 |
| IMMUNOCARD STAT CAMPY, MODEL 751530 (K090700) | Meridian Bioscience, Inc. | 2009-05-28 |
| PREMIER CAMPY, MODEL 618096 (K083464) | Meridian Bioscience, Inc. | 2009-01-30 |
| PROSPECT CAMPYLOBACTER MICROPLATE ASSAY (K982315) | Alexon - Trend, Inc. | 1998-11-18 |
| MERITEC(TM)-CAMPY (JCL) (K880389) | Meridian Diagnostics, Inc. | 1988-04-12 |
| COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI (K862814) | Institute Virion , Ltd. | 1986-09-30 |
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 |