510(k) K792575
- Device
- BACTEC BACTERIAL DETECTION SYSTEM
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K792575
- Product code
- JTA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-12-27
- Date received
- 1979-12-13
- Regulation
- 866.2560
- Classification name
- Monitor, Microbial Growth
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 1119779
- 3006988008
- 2022807
- 3013496958
- 9610126
- 1917413
- 1024879
- 1047843
- 1950204
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JTA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954923 | BACTEC FUNGAL MEDIUM | Becton Dickinson Diagnostic Instrument Systems | 1996-11-21 |
| K910835 | BACTEC NR-860 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-03-11 |
| K865021 | BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-06 |
| K853011 | BACTEC NR-730 BACTERIAL DETECTION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-07-30 |
| K842874 | RADIOMETRIC BLOOD CULTURE VIALS, AEROBE | American Micro Scan | 1984-09-12 |
| K842279 | BECTEC NR-660 BACTERIAL DETECT SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-07-20 |
| K833917 | BAC-T-SCREEN | Marion Laboratories, Inc. | 1984-01-13 |
| K834264 | REVERSE-FLOW SYSTEM | Applied Polytechnology, Inc. | 1984-01-13 |
| K810042 | BACTEC BACTERIAL DETECTION SYSTEM: #5 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-28 |
| K790297 | DETECTION SYSTEM, MS-2 ELECTROCHEMICAL | Abbott Laboratories | 1979-04-26 |
Legacy Summary#
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FDA Review#
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