510(k) K791384
- Device
- FUNGAL IMMUNODIFFUSION KIT #ID1001
- Applicant
- IMMUNO-MYCOLOGICS, INC.
- 510(k) number
- K791384
- Product code
- GMJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-08-16
- Date received
- 1979-07-11
- Regulation
- 866.3320
- Classification name
- Antigens, Histoplasma Capsulatum, All
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1524213
- 1627497
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GMJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 | Immuno-Mycologics, Inc. | 1983-05-05 |
| K813359 | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL | American Scientific Products | 1981-12-31 |
| K802130 | IMMUNO. IDENTIFICATION OF H. CAPSULATUM | Nolan Biological Laboratories, Inc. | 1980-09-26 |
| K792701 | HISTOPLASMA CAPSULATUM, ANTIGEN | Meridian Diagnostics, Inc. | 1980-01-23 |
| K792704 | HISTOPLASMA CAPSULATUM, ANTIGEN YEAST | Meridian Diagnostics, Inc. | 1980-01-17 |
| K792708 | HISTOPLASMA CAPSULATUM, MYCELIAL PHASE | Meridian Diagnostics, Inc. | 1980-01-17 |
| K792711 | HISTOPLASMA CAPSULATUM, ANTISERUM | Meridian Diagnostics, Inc. | 1980-01-17 |
| K791393 | HISTOPLASMA YEAST ANTI #CF10021X | Immuno-Mycologics, Inc. | 1979-08-16 |
| K791394 | HISTOPLASMA MYCELIAL #CF10020X | Immuno-Mycologics, Inc. | 1979-08-16 |
| K760826 | HISTOPLASMA MYCELIAL ANTIGEN | I M, Inc. | 1976-11-01 |
| K760827 | HISTOPLASMA YEAST ANTIGEN | I M, Inc. | 1976-11-01 |
Legacy Summary#
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FDA Review#
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