Cleared Traditional

K791404 - LANCER L-INA ANTI-C3

K791404 is an FDA 510(k) clearance for LANCER L-INA ANTI-C3, manufactured by Sherwood Medical Co.. The device is a Class 2 Immunology device with product code CZW cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K791404 · Sherwood Medical Co. · Immunology device
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Oct 1979
Decision
79d
Days
Class 2
Risk

K791404 is an FDA 510(k) clearance for the LANCER L-INA ANTI-C3. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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.

FDA 510(k) Submission Details - K791404

510(k) Number K791404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1979
Decision Date October 17, 1979
Days to Decision 79 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
26d faster than avg
Panel avg: 105d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZW Device Classification - Class 2, Special Controls

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - CZW Complement C3, Antigen, Antiserum, Control

All 43
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K791404.
SCRIPPSYSTEM C3 RID KIT
K810501 · Scripps-Miles, Inc. · Apr 1981
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K801363 · J.T. Baker Chemical Co. · Jun 1980
COMPLEMENT C3 REAGENT SYSTEM
K800212 · Calbiochem-Behring Corp. · Feb 1980
NEPHELRATE ANTISERUMS C3C
K781653 · Antibodies, Inc. · Nov 1978
SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN
K760148 · Oxford Laboratories, Inc. · Jul 1976
K791404 · LANCER L-INA ANTI-C3
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