Cleared Traditional

K770963 - GOAT ANTISERUM IGM NEPHELOMHTRIC

K770963 is the FDA 510(k) clearance for GOAT ANTISERUM IGM NEPHELOMHTRIC by Kallestad Laboratories, Inc.. It is a Class 2 Immunology device (product code DFT) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K770963 · Kallestad Laboratories, Inc. · Immunology device
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Jun 1977
Decision
28d
Days
Class 2
Risk

K770963 is an FDA 510(k) clearance for the GOAT ANTISERUM IGM NEPHELOMHTRIC. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K770963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1977
Decision Date June 24, 1977
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
76d faster than avg
Panel avg: 104d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFT Igm, 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 Immunology devices follow this clearance model.

Regulatory Peers - DFT Igm, Antigen, Antiserum, Control

All 22
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K770963.
IMMUNOGLOBULIN M REAGENT SYSTEM
K800167 · Calbiochem-Behring Corp. · Feb 1980
LANCER L-INA ANTI-IGM
K791402 · Sherwood Medical Co. · Oct 1979
IMMUNOGLOBULIN M NEPHEL. ASSAY
K772254 · Kallestad Laboratories, Inc. · Dec 1977
LAS-R HUMAN HAPTOGLOBIN TEST
K760917 · Hyland Therapeutic Div., Travenol Laboratories · Dec 1976