DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
FDA 510(k) clearance K844407 · decided 1985-01-25
Clearance details
- K-number
- K844407
- Device name
- DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1984-11-13
- Decision date
- 1985-01-25
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- GTJ
- Device class
- 2
- Regulation number
- 866.3390
- 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 |
|---|---|---|
| DIRECTIGEN MENINGITIS COMBO TEST (K952791) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996-05-30 |
| DIRECTIGEN MENINGITIS COMBO TEST KIT (K915330) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-03-23 |
| SLIDEX MENINGITE-KIT 5 (K910210) | Vitek Systems, Inc. | 1991-08-12 |
| BACTIGEN(R) N. MENINGITIDIS (K885004) | Armkel, LLC | 1989-02-07 |
| IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT (K870089) | Microscan Div. Baxter Healthcare Corp. | 1987-03-17 |
| WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (K854851) | Wellcome Diagnostics | 1986-02-04 |
| WELLCOGEN BACTERIAL ANTIGEN KIT (K854852) | Wellcome Diagnostics | 1986-02-04 |
| PHADEBACT CSF TEST (K844999) | Pharmacia, Inc. | 1985-10-17 |
| WILLCOGEN MENINGITIDIS KIT ZL25 (K851691) | Wellcome Diagnostics | 1985-06-10 |
| MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 (K844762) | Wellcome Diagnostics | 1985-06-04 |
| BACTIGEN - N.MENNINIGITIDIS TEST (K841907) | Armkel, LLC | 1984-07-06 |
| WELLCOGEN N. MENINGITIDIS A,C,Y W135 (K833063) | Wellcome Diagnostics | 1984-01-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labe recall (Z-1559-2008) | BD Diagnostic Systems / Lee Laboratories | 2008-08-08 |
| BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were label recall (Z-1560-2008) | BD Diagnostic Systems / Lee Laboratories | 2008-08-08 |
| BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were label recall (Z-1561-2008) | BD Diagnostic Systems / Lee Laboratories | 2008-08-08 |
| BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were labe recall (Z-1562-2008) | BD Diagnostic Systems / Lee Laboratories | 2008-08-08 |
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 |