BBL STAPHYSLIDE TEST
FDA 510(k) clearance K821962 · decided 1982-07-30
Clearance details
- K-number
- K821962
- Device name
- BBL STAPHYSLIDE TEST
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1982-07-01
- Decision date
- 1982-07-30
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- JWX
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| BINAXNOX STAPHYLOCOCCUS AUREUS TEST (K090964) | Binax, Inc. | 2009-12-16 |
| STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS (K972030) | Oxoid , Ltd. | 1997-09-08 |
| REMEL STAPH LATEX KIT (K964315) | Remel, L.P. | 1997-02-07 |
| STAPHAUREX PLUS(TM) (K945538) | Murex Diagnostics Limitd | 1995-06-01 |
| STAPH-A-LEX(TM) SYSTEM (K926173) | Trinity Laboratories, Inc. | 1993-08-10 |
| SLIDEX STAPH-KIT (K923212) | Biomerieux Vitek, Inc. | 1992-09-28 |
| VISI-STAPH (K905617) | Connecticut Diagnostics, Ltd. | 1991-03-29 |
| AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT (K902259) | Orthomet, Inc. | 1990-06-18 |
| STAPHSLIDE (K874019) | Ncs Diagnostics, Inc. | 1987-10-28 |
| NEG COMBO BREAKPOINT PANEL POS COMBO (K854278) | American Micro Scan | 1986-03-04 |
| V-TREND KIT STAPH LATEX TEST (K855220) | Texas Immunology, Inc. | 1986-03-03 |
| RAPI - STAPH (K852997) | Advanced Medical Technology, Inc. | 1985-08-19 |
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 |