Cleared Traditional

K951435 - AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (FDA 510(k) Clearance)

Class I Chemistry device.

K951435 · Aalto Scientific, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
36d
Days
Class 1
Risk

K951435 is an FDA 510(k) clearance for the AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Aalto Scientific, Ltd. (Vista, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 Aalto Scientific, Ltd. devices

Submission Details

510(k) Number K951435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date May 02, 1995
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJR Electrolyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.