Cleared Traditional

K792700 - ASPERGILLUS SP, COMPLEMENT FIXATION

K792700 is an FDA 510(k) clearance for ASPERGILLUS SP, manufactured by Meridian Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JWT cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K792700 · Meridian Diagnostics, Inc. · Microbiology device

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Jan 1980

Decision

21d

Days

Class 1

Risk

K792700 is an FDA 510(k) clearance for the ASPERGILLUS SP, COMPLEMENT FIXATION. Classified as Antigen, Cf, Aspergillus Spp. (product code JWT), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3040 - 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.

FDA 510(k) Submission Details - K792700

510(k) Number	K792700 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 27, 1979
Decision Date	January 17, 1980
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

81d faster than avg

Panel avg: 102d · This submission: 21d

Pathway characteristics

Predicate-based equivalence.

JWT Device Classification - Class 1, General Controls

Product Code	JWT Antigen, Cf, Aspergillus Spp.
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 866.3040

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JWT Antigen, Cf, Aspergillus Spp.

Devices cleared under the same product code (JWT) and FDA review panel - the closest regulatory comparables to K792700.

REAGENTS FOR SERODIAGNOSIS OF ASPERGILL

K812740 · Nolan Biological Laboratories, Inc. · Oct 1981

ASPERGILLUS MYCELIAL ANTIGEN #CF10024X

K791387 · Immuno-Mycologics, Inc. · Aug 1979

ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU

K790672 · Diagnostica, Inc. · May 1979

ASPERGILLUS MYCELIAL ANTIGEN

K760830 · I M, Inc. · Nov 1976

FDA 510(k) Resources - Microbiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K792700

Meridian Diagnostics, Inc.

Mchenry, IL · US

Regulatory profile

92 submissions 92 cleared

100% clearance rate · Active in Microbiology

View all devices by Meridian Diagnostics, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 17, 1980. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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510k Database

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Regulatory data since 1976

FDA monthly sync November 6, 2026