Cleared Traditional

K790705 - ANTISERUM TO HUMAN IGM

K790705 is an FDA 510(k) clearance for ANTISERUM TO HUMAN IGM, manufactured by Kent Laboratories, Inc.. The device is a Class 2 Immunology device with product code DAO cleared through the Traditional 510(k) pathway .

K790705 · Kent Laboratories, Inc. · Immunology device
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Apr 1979
Decision
-
Days
Class 2
Risk

K790705 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN IGM. Classified as Igm (mu Chain Specific), Antigen, Antiserum, Control (product code DAO), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1979.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kent Laboratories, Inc. devices

FDA 510(k) Submission Details - K790705

510(k) Number K790705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received April 12, 1979
Decision Date April 12, 1979
Days to Decision -
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAO Device Classification - Class 2, Special Controls

Product Code DAO Igm (mu Chain Specific), 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.