Cleared Traditional

K822678 - FITC ANTISERA TO HUMAN GOBULIN

K822678 is the FDA 510(k) clearance for FITC ANTISERA TO HUMAN GOBULIN by Amico Lab, Inc.. It is a Class 2 Microbiology device (product code DFH) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K822678 · Amico Lab, Inc. · Microbiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Nov 1982

Decision

75d

Days

Class 2

Risk

K822678 is an FDA 510(k) clearance for the FITC ANTISERA TO HUMAN GOBULIN. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Amico Lab, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 17, 1982 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5550 - 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 Amico Lab, Inc. devices

Submission Details

510(k) Number	K822678 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 03, 1982
Decision Date	November 17, 1982
Days to Decision	75 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

27d faster than avg

Panel avg: 102d · This submission: 75d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DFH Kappa, Antigen, Antiserum, Control
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.5550

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 - DFH Kappa, Antigen, Antiserum, Control

All 53

Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K822678.

FITC ANTISERA TO HUMAN IGA

K822675 · Amico Lab, Inc. · Nov 1982

FITC ANTISERA TO HUMAN IGG

K822676 · Amico Lab, Inc. · Nov 1982

FITC ANTISERA TO HUMAN IGM

K822677 · Amico Lab, Inc. · Nov 1982

FITC ANTISERA TO HUMAN C3

K822679 · Amico Lab, Inc. · Nov 1982

RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA

K823121 · Amico Lab, Inc. · Nov 1982

DAKO PAP KIT K504

K812485 · Dako Corp. · Feb 1982

Related FDA 510(k) Regulatory Insights

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

Manufacturer of K822678

Amico Lab, Inc.

Mchenry, IL · US

Regulatory profile

32 submissions 32 cleared

100% clearance rate · Active in Microbiology

Data Intelligence Layer

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 . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active