Antiserum, Positive Control, Histoplasma Capsulatum
The Histoplasma Capsulatum Positive Control Antiserum is a reference material used to validate serological assays for the detection of Histoplasma capsulatum, ensuring test accuracy in the diagnosis of histoplasmosis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMK, regulated under 21 CFR 866.3320 in the Microbiology specialty.
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Basic Information
- Product Code
- GMK
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K792694 | NEGATIVE CONTROL SERUM | Jan 24, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792692 | IMMUNODIFFUSION BAND INTENSIFYING FLUID | Jan 24, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792718 | HISTOPLASMA CAPSULATUM, ANTISERUM | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792679 | HISTOPLASMA CAPSULATUM, ANTISERUM | Jan 17, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K791395 | ANTI-HISTOPLASMA SERUM #CF10025X | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K791392 | ANTI-HISTOPLASMA SERUM #CF10026X | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K791390 | ANTI-BLASTOMYCES SERUM #CF10027X | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
| K760832 | ANTI-HISTOPLASMA CONTROL SERUM (YEAST) | Nov 01, 1976 | Substantially Equivalent | I M, Inc. |
| K760831 | ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) | 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.