Antigens, Histoplasma Capsulatum, All
The Histoplasma Capsulatum Antigens (All Types) are microbiology reagents used in serological tests to detect antibodies against Histoplasma capsulatum, the causative agent of histoplasmosis, an endemic fungal infection affecting the lungs and other organs. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMJ, regulated under 21 CFR 866.3320 in the Microbiology specialty.
Basic Information
- Product Code
- GMJ
- Device Class
- FDA class 2
- Regulation Number
- 866.3320
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 | May 05, 1983 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K813359 | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL | Dec 31, 1981 | Substantially Equivalent | American Scientific Products |
| K802130 | IMMUNO. IDENTIFICATION OF H. CAPSULATUM | Sep 26, 1980 | Substantially Equivalent | Nolan Biological Laboratories, Inc. |
| K792701 | HISTOPLASMA CAPSULATUM, ANTIGEN | Jan 23, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792711 | HISTOPLASMA CAPSULATUM, ANTISERUM | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792708 | HISTOPLASMA CAPSULATUM, MYCELIAL PHASE | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792704 | HISTOPLASMA CAPSULATUM, ANTIGEN YEAST | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K791394 | HISTOPLASMA MYCELIAL #CF10020X | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K791393 | HISTOPLASMA YEAST ANTI #CF10021X | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K791384 | FUNGAL IMMUNODIFFUSION KIT #ID1001 | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K760827 | HISTOPLASMA YEAST ANTIGEN | Nov 01, 1976 | Substantially Equivalent | I M, Inc. |
| K760826 | HISTOPLASMA MYCELIAL ANTIGEN | Nov 01, 1976 | Substantially Equivalent | I M, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.