GMK — Antiserum, Positive Control, Histoplasma Capsulatum Class II
FDA Device Classification
Classification Details
- Product Code
- GMK
- 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 |
|---|
| K792694 | meridian diagnostics | NEGATIVE CONTROL SERUM | January 24, 1980 |
| K792692 | meridian diagnostics | IMMUNODIFFUSION BAND INTENSIFYING FLUID | January 24, 1980 |
| K792679 | meridian diagnostics | HISTOPLASMA CAPSULATUM, ANTISERUM | January 17, 1980 |
| K792718 | meridian diagnostics | HISTOPLASMA CAPSULATUM, ANTISERUM | January 17, 1980 |
| K791390 | immuno-mycologics | ANTI-BLASTOMYCES SERUM #CF10027X | August 16, 1979 |
| K791392 | immuno-mycologics | ANTI-HISTOPLASMA SERUM #CF10026X | August 16, 1979 |
| K791395 | immuno-mycologics | ANTI-HISTOPLASMA SERUM #CF10025X | August 16, 1979 |
| K760832 | i m | ANTI-HISTOPLASMA CONTROL SERUM (YEAST) | November 1, 1976 |
| K760831 | i m | ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) | November 1, 1976 |