Cleared Traditional

K780960 - SERUM, CONTROL, DRUGS, ANTIARRYTHMIC

K780960 is an FDA 510(k) clearance for SERUM, manufactured by Vitek Systems, Inc.. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K780960 · Vitek Systems, Inc. · Toxicology device
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Dec 1978
Decision
178d
Days
Class 1
Risk

K780960 is an FDA 510(k) clearance for the SERUM, CONTROL, DRUGS, ANTIARRYTHMIC. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Vitek Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitek Systems, Inc. devices

FDA 510(k) Submission Details - K780960

510(k) Number K780960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1978
Decision Date December 07, 1978
Days to Decision 178 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
91d slower than avg
Panel avg: 87d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

Product Code DIF Drug Mixture 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.