DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
FDA 510(k) clearance K893753 · decided 1989-10-16
Clearance details
- K-number
- K893753
- Device name
- DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1989-05-19
- Decision date
- 1989-10-16
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- LHK
- Device class
- 2
- Regulation number
- 866.3165
- 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 |
|---|---|---|
| CANDIDA DETECTION SYSTEM (K823016) | Ramco Laboratories, Inc. | 1982-12-28 |
| REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS (K812741) | Nolan Biological Laboratories, Inc. | 1981-10-23 |
| CANDIDA IMMUNODIFFUSION SYSTEM (K812186) | American Scientific Products | 1981-08-25 |
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 |