GTJ — Antisera, All Groups, N. Meningitidis Class II
FDA Device Classification
Classification Details
- Product Code
- GTJ
- Device Class
- Class II
- Regulation Number
- 866.3390
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K952791 | bd becton dickinson vacutainer systems preanalytic | DIRECTIGEN MENINGITIS COMBO TEST | May 30, 1996 |
| K915330 | bd becton dickinson vacutainer systems preanalytic | DIRECTIGEN MENINGITIS COMBO TEST KIT | March 23, 1992 |
| K910210 | vitek systems | SLIDEX MENINGITE-KIT 5 | August 12, 1991 |
| K885004 | armkel | BACTIGEN(R) N. MENINGITIDIS | February 7, 1989 |
| K870089 | microscan div. baxter healthcare | IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT | March 17, 1987 |
| K854852 | wellcome diagnostics | WELLCOGEN BACTERIAL ANTIGEN KIT | February 4, 1986 |
| K854851 | wellcome diagnostics | WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 | February 4, 1986 |
| K844999 | pharmacia | PHADEBACT CSF TEST | October 17, 1985 |
| K851691 | wellcome diagnostics | WILLCOGEN MENINGITIDIS KIT ZL25 | June 10, 1985 |
| K844762 | wellcome diagnostics | MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 | June 4, 1985 |
| K844407 | bd becton dickinson vacutainer systems preanalytic | DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST | January 25, 1985 |
| K841907 | armkel | BACTIGEN - N.MENNINIGITIDIS TEST | July 6, 1984 |
| K833063 | wellcome diagnostics | WELLCOGEN N. MENINGITIDIS A,C,Y W135 | January 10, 1984 |
| K823880 | armkel | BACTIGEN-N. MENINGITIDIS | March 9, 1983 |
| K822810 | pharmacia | PHADEBACT CSF TEST 20 | December 30, 1982 |
| K771562 | burroughs wellcome | AGGLUTINATING SERUM W135 | August 25, 1977 |