GMJ
12 FDA 510(k) clearances · Product code
31 daysmedian time to decision
50 days90th percentile
12clearances measured
FDA profile
- Official device name
- Antigens, Histoplasma Capsulatum, All
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3320
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LA-HISTO ANTIBODY SYSTEM #HL 1001 (K830837) | Immuno-Mycologics, Inc. | 1983-05-05 |
| MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL (K813359) | American Scientific Products | 1981-12-31 |
| IMMUNO. IDENTIFICATION OF H. CAPSULATUM (K802130) | Nolan Biological Laboratories, Inc. | 1980-09-26 |
| HISTOPLASMA CAPSULATUM, ANTIGEN (K792701) | Meridian Diagnostics, Inc. | 1980-01-23 |
| HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (K792708) | Meridian Diagnostics, Inc. | 1980-01-17 |
| HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (K792704) | Meridian Diagnostics, Inc. | 1980-01-17 |
| HISTOPLASMA CAPSULATUM, ANTISERUM (K792711) | Meridian Diagnostics, Inc. | 1980-01-17 |
| HISTOPLASMA MYCELIAL #CF10020X (K791394) | Immuno-Mycologics, Inc. | 1979-08-16 |
| FUNGAL IMMUNODIFFUSION KIT #ID1001 (K791384) | Immuno-Mycologics, Inc. | 1979-08-16 |
| HISTOPLASMA YEAST ANTI #CF10021X (K791393) | Immuno-Mycologics, Inc. | 1979-08-16 |
| HISTOPLASMA YEAST ANTIGEN (K760827) | I M, Inc. | 1976-11-01 |
| HISTOPLASMA MYCELIAL ANTIGEN (K760826) | I M, Inc. | 1976-11-01 |
Track GMJ automatically
Every clearance here is in the API, with alerts when new ones post.