Cleared Traditional

K930397 - 16 X 125 MM TEST TUBE, CATALOG (FDA 510(k) Clearance)

Class I Pathology device.

K930397 · Proteins Intl., Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
57d
Days
Class 1
Risk

K930397 is an FDA 510(k) clearance for the 16 X 125 MM TEST TUBE, CATALOG. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Proteins Intl., Inc. (Rochester Hills, US). The FDA issued a Cleared decision on March 24, 1993 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2280 - the FDA pathology 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 Proteins Intl., Inc. devices

Submission Details

510(k) Number K930397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date March 24, 1993
Days to Decision 57 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 77d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
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.