Product code GMK— Microbiology
HISTOPLASMA CAPSULATUM, ANTISERUM
- Classification name
- Antiserum, Positive Control, Histoplasma Capsulatum
- Device class
- Class 2
- Regulation
- 21 CFR 866.3320
- Advisory panel
- Microbiology
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code GMK
FDA has cleared devices under product code GMK between 1976 and 1980, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1980
- 1979
- 1976
Top applicants under product code GMK
Recent clearances under product code GMK
- K792692 — IMMUNODIFFUSION BAND INTENSIFYING FLUID
- K792694 — NEGATIVE CONTROL SERUM
- K792679 — HISTOPLASMA CAPSULATUM, ANTISERUM
- K792718 — HISTOPLASMA CAPSULATUM, ANTISERUM
- K791390 — ANTI-BLASTOMYCES SERUM #CF10027X
- K791392 — ANTI-HISTOPLASMA SERUM #CF10026X
- K791395 — ANTI-HISTOPLASMA SERUM #CF10025X
- K760831 — ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL)
- K760832 — ANTI-HISTOPLASMA CONTROL SERUM (YEAST)
Data sourced from openFDA. This site is unofficial and independent of the FDA.