Cleared Traditional

K921939 - SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) (FDA 510(k) Clearance)

Class I Toxicology device.

K921939 · Heraeus Kulzer, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
83d
Days
Class 1
Risk

K921939 is an FDA 510(k) clearance for the SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR). Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Mishawaka, US). The FDA issued a Cleared decision on July 16, 1992 after a review of 83 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K921939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1992
Decision Date July 16, 1992
Days to Decision 83 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 87d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.