Cleared Traditional

K791283 - ANTI-HUMAN LAMBDA SERUM

K791283 is an FDA 510(k) clearance for ANTI-HUMAN LAMBDA SERUM, manufactured by Diagnostica, Inc.. The device is a Class 2 Immunology device with product code DEH cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K791283 · Diagnostica, Inc. · Immunology device
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Nov 1979
Decision
140d
Days
Class 2
Risk

K791283 is an FDA 510(k) clearance for the ANTI-HUMAN LAMBDA SERUM. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979 after a review of 140 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K791283

510(k) Number K791283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1979
Decision Date November 27, 1979
Days to Decision 140 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
35d slower than avg
Panel avg: 105d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEH Device Classification - Class 2, Special Controls

Product Code DEH Lambda, 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 - DEH Lambda, Antigen, Antiserum, Control

All 52
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K791283.
GOAT ANTI-HUMAN LAMBA
K832270 · Gelco Diagnostics, Inc. · Oct 1983
GOAT ANTI-HUMAN LAMBA AFFINITY
K832261 · Gelco Diagnostics, Inc. · Oct 1983
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
K812662 · Dako Corp. · Sep 1981
GOAR ANTI-HUMAN LAMBODA CHAIN
K791115 · Protos Laboratories · Aug 1979
LAMBDA SERUM (FREE) ANTI-HUMAN
K781025 · Icl Scientific · Jul 1978
ANTI-HUMAN LAMBDA SERUM
K781220 · Icl Scientific · Jul 1978
K791283 · ANTI-HUMAN LAMBDA SERUM
Download PDF Diagnostica, Inc.