Cleared Traditional

K791395 - ANTI-HISTOPLASMA SERUM #CF10025X

K791395 is the FDA 510(k) clearance for ANTI-HISTOPLASMA SERUM #CF10025X by Immuno-Mycologics, Inc.. It is a Class 2 Microbiology device (product code GMK) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K791395 · Immuno-Mycologics, Inc. · Microbiology device
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Aug 1979
Decision
36d
Days
Class 2
Risk

K791395 is an FDA 510(k) clearance for the ANTI-HISTOPLASMA SERUM #CF10025X. Classified as Antiserum, Positive Control, Histoplasma Capsulatum (product code GMK), Class II - Special Controls.

Submitted by Immuno-Mycologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3320 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immuno-Mycologics, Inc. devices

Submission Details

510(k) Number K791395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1979
Decision Date August 16, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 102d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMK Antiserum, Positive Control, Histoplasma Capsulatum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GMK Antiserum, Positive Control, Histoplasma Capsulatum

Devices cleared under the same product code (GMK) and FDA review panel - the closest regulatory comparables to K791395.
NEGATIVE CONTROL SERUM
K792694 · Meridian Diagnostics, Inc. · Jan 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792679 · Meridian Diagnostics, Inc. · Jan 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792718 · Meridian Diagnostics, Inc. · Jan 1980
ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL)
K760831 · I M, Inc. · Nov 1976
ANTI-HISTOPLASMA CONTROL SERUM (YEAST)
K760832 · I M, Inc. · Nov 1976