BACTEC FUNGAL MEDIUM
FDA 510(k) clearance K954923 · decided 1996-11-21
Clearance details
- K-number
- K954923
- Device name
- BACTEC FUNGAL MEDIUM
- Applicant
- Becton Dickinson Diagnostic Instrument Systems
- Decision
- Substantially Equivalent
- Date received
- 1995-10-26
- Decision date
- 1996-11-21
- Days to decision
- 392 days
- Clearance type
- Traditional
- Product code
- JTA
- Device class
- 1
- Regulation number
- 866.2560
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, 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 |
|---|---|---|
| BACTEC NR-860 (K910835) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-03-11 |
| BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM (K865021) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-06 |
| BACTEC NR-730 BACTERIAL DETECTION SYSTEM (K853011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-07-30 |
| RADIOMETRIC BLOOD CULTURE VIALS, AEROBE (K842874) | American Micro Scan | 1984-09-12 |
| BECTEC NR-660 BACTERIAL DETECT SYS (K842279) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-07-20 |
| BAC-T-SCREEN (K833917) | Marion Laboratories, Inc. | 1984-01-13 |
| REVERSE-FLOW SYSTEM (K834264) | Applied Polytechnology, Inc. | 1984-01-13 |
| BACTEC BACTERIAL DETECTION SYSTEM: #5 (K810042) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-28 |
| BACTEC BACTERIAL DETECTION SYSTEM (K792575) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-12-27 |
| DETECTION SYSTEM, MS-2 ELECTROCHEMICAL (K790297) | Abbott Laboratories | 1979-04-26 |
Recalls involving this device
No recalls on record reference this clearance.