Cleared Traditional

K792014 - LANCER L-INA BUFFER, POLYMER, WASH SOLU (FDA 510(k) Clearance)

Class I Immunology device.

K792014 · Sherwood Medical Industries · Immunology device
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Nov 1979
Decision
39d
Days
Class 1
Risk

K792014 is an FDA 510(k) clearance for the LANCER L-INA BUFFER, POLYMER, WASH SOLU. Classified as Nephelometer (product code JZW), Class I - General Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4540 - 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 Sherwood Medical Industries devices

Submission Details

510(k) Number K792014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1979
Decision Date November 13, 1979
Days to Decision 39 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 104d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZW Nephelometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.