Cleared Traditional

AC/AD LINEARITY VERIFIERS (K982217) - FDA 510(k) Clearance

Class I Toxicology device.

K982217 · Sc Calibrators & Controls, LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
8d
Days
Class 1
Risk

K982217 is an FDA 510(k) clearance for the AC/AD LINEARITY VERIFIERS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Sc Calibrators & Controls, LLC (Santa Monica, US). The FDA issued a Cleared decision on July 2, 1998 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.

View all Sc Calibrators & Controls, LLC devices

Submission Details

510(k) Number K982217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1998
Decision Date July 02, 1998
Days to Decision 8 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 87d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

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.

Regulatory Peers - DIF Drug Mixture Control Materials

All 201
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