ANAEROBE MIC/ID TEMPLATE, & TAXONOMY
FDA 510(k) clearance K830964 · decided 1983-05-04
Clearance details
- K-number
- K830964
- Device name
- ANAEROBE MIC/ID TEMPLATE, & TAXONOMY
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1983-03-28
- Decision date
- 1983-05-04
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- JSP
- 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 |
|---|---|---|
| LYFO(TM) DIFFERENTIAL DISK (K945488) | Microbiologics, Inc. | 1995-05-11 |
| LYFO(TM) DIFFERENTIAL DISK (K945489) | Microbiologics, Inc. | 1995-05-11 |
| LYFO(TM) DIFFERENTIAL DISK (K945487) | Microbiologics, Inc. | 1995-05-11 |
| BBLCRYSTAL ANAEROBE ID SYSTEM (K944528) | Becton Dickinson Microbiology Systems | 1995-03-07 |
| VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION (K910666) | Vitek Systems, Inc. | 1991-04-03 |
| VITEK ANAEROBE IDENTIFICATION CARD (K900996) | Vitek Systems, Inc. | 1990-05-11 |
| B. FRAGTEX (K881380) | American Biomedical Products, Inc. | 1988-10-06 |
| IDS RAPID ANA SYSTEM (K882960) | Innovative Diagnostic Systems, Inc. | 1988-08-12 |
| DIAGNOSTIC REAGENT PET-RPLA (K855235) | Oxoid U.S.A., Inc. | 1986-11-04 |
| ANAEROBE RAPID CHROMOGENIC ID PANEL (K862332) | American Micro Scan | 1986-08-27 |
| ANAEROBE KIT (K850052) | Austin Biological Laboratories | 1985-03-05 |
| AMS ANA CARD (K843686) | Vitek Systems, Inc. | 1984-12-12 |
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 |