Cleared Traditional

K792692 - IMMUNODIFFUSION BAND INTENSIFYING FLUID

K792692 is an FDA 510(k) clearance for IMMUNODIFFUSION BAND INTENSIFYING FLUID, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Immunology device with product code GMK cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K792692 · Meridian Diagnostics, Inc. · Immunology device
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Jan 1980
Decision
28d
Days
Class 2
Risk

K792692 is an FDA 510(k) clearance for the IMMUNODIFFUSION BAND INTENSIFYING FLUID. Classified as Antiserum, Positive Control, Histoplasma Capsulatum (product code GMK), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1980 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3320 - the FDA immunology 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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K792692

510(k) Number K792692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1979
Decision Date January 24, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 105d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMK Device Classification - Class 2, Special Controls

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 Immunology devices follow this clearance model.

Regulatory Peers - GMK Antiserum, Positive Control, Histoplasma Capsulatum

All 8
Devices cleared under the same product code (GMK) and FDA review panel - the closest regulatory comparables to K792692.
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-BLASTOMYCES SERUM #CF10027X
K791390 · Immuno-Mycologics, Inc. · Aug 1979
ANTI-HISTOPLASMA SERUM #CF10026X
K791392 · Immuno-Mycologics, Inc. · Aug 1979
ANTI-HISTOPLASMA SERUM #CF10025X
K791395 · Immuno-Mycologics, Inc. · Aug 1979