GTJ — Antisera, All Groups, N. Meningitidis Class II
FDA product code GTJ covers "Antisera, All Groups, N. Meningitidis", a Class II medical device regulated under 21 CFR 866.3390. Submissions are reviewed by the Microbiology panel. At least 16 recent 510(k) clearances have been granted under this product code.
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 |