Cleared Traditional

K780142 - ANTICONVULSANT CONTROL SERUM

K780142 is an FDA 510(k) clearance for ANTICONVULSANT CONTROL SERUM, manufactured by Mcdonnell Douglas Corp.. The device is a Class 1 Toxicology device with product code LAS cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K780142 · Mcdonnell Douglas Corp. · Toxicology device
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Feb 1978
Decision
8d
Days
Class 1
Risk

K780142 is an FDA 510(k) clearance for the ANTICONVULSANT CONTROL SERUM. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Mcdonnell Douglas Corp. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1978 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology 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 - K780142

510(k) Number K780142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1978
Decision Date February 03, 1978
Days to Decision 8 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 87d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

LAS Device Classification - Class 1, General Controls

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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.

K780142 · ANTICONVULSANT CONTROL SERUM
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