GMK
9 FDA 510(k) clearances · Product code
28 daysmedian time to decision
36 days90th percentile
9clearances measured
FDA profile
- Official device name
- Antiserum, Positive Control, Histoplasma Capsulatum
- 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 |
|---|---|---|
| NEGATIVE CONTROL SERUM (K792694) | Meridian Diagnostics, Inc. | 1980-01-24 |
| IMMUNODIFFUSION BAND INTENSIFYING FLUID (K792692) | Meridian Diagnostics, Inc. | 1980-01-24 |
| HISTOPLASMA CAPSULATUM, ANTISERUM (K792679) | Meridian Diagnostics, Inc. | 1980-01-17 |
| HISTOPLASMA CAPSULATUM, ANTISERUM (K792718) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ANTI-BLASTOMYCES SERUM #CF10027X (K791390) | Immuno-Mycologics, Inc. | 1979-08-16 |
| ANTI-HISTOPLASMA SERUM #CF10025X (K791395) | Immuno-Mycologics, Inc. | 1979-08-16 |
| ANTI-HISTOPLASMA SERUM #CF10026X (K791392) | Immuno-Mycologics, Inc. | 1979-08-16 |
| ANTI-HISTOPLASMA CONTROL SERUM (YEAST) (K760832) | I M, Inc. | 1976-11-01 |
| ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) (K760831) | I M, Inc. | 1976-11-01 |
Track GMK automatically
Every clearance here is in the API, with alerts when new ones post.