GMJ — Antigens, Histoplasma Capsulatum, All Class II
FDA product code GMJ covers "Antigens, Histoplasma Capsulatum, All", a Class II medical device regulated under 21 CFR 866.3320. Submissions are reviewed by the Microbiology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GMJ
- Device Class
- Class II
- Regulation Number
- 866.3320
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K830837 | immuno-mycologics | LA-HISTO ANTIBODY SYSTEM #HL 1001 | May 5, 1983 |
| K813359 | american scientific products | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL | December 31, 1981 |
| K802130 | nolan biological laboratories | IMMUNO. IDENTIFICATION OF H. CAPSULATUM | September 26, 1980 |
| K792701 | meridian diagnostics | HISTOPLASMA CAPSULATUM, ANTIGEN | January 23, 1980 |
| K792711 | meridian diagnostics | HISTOPLASMA CAPSULATUM, ANTISERUM | January 17, 1980 |
| K792704 | meridian diagnostics | HISTOPLASMA CAPSULATUM, ANTIGEN YEAST | January 17, 1980 |
| K792708 | meridian diagnostics | HISTOPLASMA CAPSULATUM, MYCELIAL PHASE | January 17, 1980 |
| K791394 | immuno-mycologics | HISTOPLASMA MYCELIAL #CF10020X | August 16, 1979 |
| K791393 | immuno-mycologics | HISTOPLASMA YEAST ANTI #CF10021X | August 16, 1979 |
| K791384 | immuno-mycologics | FUNGAL IMMUNODIFFUSION KIT #ID1001 | August 16, 1979 |
| K760826 | i m | HISTOPLASMA MYCELIAL ANTIGEN | November 1, 1976 |
| K760827 | i m | HISTOPLASMA YEAST ANTIGEN | November 1, 1976 |