GMK is the FDA product code for Antiserum, Positive Control, Histoplasma Capsulatum, a class II device type, regulated under 21 CFR 866.3320. As of 2026-09-10 , FDA records hold 9 510(k) clearances under this code, the most recent dated 1980-01-24 , and no recalls.
Classification record Product code GMK Device name Antiserum, Positive Control, Histoplasma Capsulatum Regulation 21 CFR 866.3320 Device class Class II Review panel Microbiology Submission type 510(k) exempt Implant No Life sustaining or supporting No GMP exempt No Third party review eligible No Ingested clearances 9 Ingested recalls 0
Clearances, product code GMK By decision year 9 clearances under product code GMK with a decision year between 1976 and 1980, 1980 the highest year at 4. Show the numbers
Applicants with the most clearances Product code GMK
Companies listing this code with FDA Companies whose registered establishments list this code FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
Recent clearances Product code GMK K792694 Class II Negative Control Serum Meridian Diagnostics, Inc. / cleared 1980-01-24 K792692 Class II Immunodiffusion Band Intensifying Fluid Meridian Diagnostics, Inc. / cleared 1980-01-24 K792718 Class II Histoplasma Capsulatum, Antiserum Meridian Diagnostics, Inc. / cleared 1980-01-17 K792679 Class II Histoplasma Capsulatum, Antiserum Meridian Diagnostics, Inc. / cleared 1980-01-17 K791395 Class II Anti-Histoplasma Serum #Cf10025x Immuno-Mycologics, Inc. / cleared 1979-08-16 K791392 Class II Anti-Histoplasma Serum #Cf10026x Immuno-Mycologics, Inc. / cleared 1979-08-16 K791390 Class II Anti-Blastomyces Serum #Cf10027x Immuno-Mycologics, Inc. / cleared 1979-08-16 K760832 Class II Anti-Histoplasma Control Serum (Yeast) I M, Inc. / cleared 1976-11-01 K760831 Class II Anti-Histoplasma Control Serum(mycelial) I M, Inc. / cleared 1976-11-01
Recent recalls Product code GMK FDA records show no recalls under product code GMK.
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About this record Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.
MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.
Data as of 2026-10-05 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this product code on fda.gov ↗ (opens on fda.gov)
