Cleared Traditional

K820360 - AALTO LDH ISOENZYME CONTROL SERUM

K820360 is an FDA 510(k) clearance for AALTO LDH ISOENZYME CONTROL SERUM, manufactured by Aalto Scientific, Ltd.. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K820360 · Aalto Scientific, Ltd. · Chemistry device
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Mar 1982
Decision
23d
Days
Class 1
Risk

K820360 is an FDA 510(k) clearance for the AALTO LDH ISOENZYME CONTROL SERUM. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Aalto Scientific, Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 23 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

FDA 510(k) Submission Details - K820360

510(k) Number K820360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1982
Decision Date March 04, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

JJT Device Classification - Class 1, General Controls

Product Code JJT Enzyme 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.

Regulatory Peers - JJT Enzyme Controls (assayed And Unassayed)

All 79
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K820360.
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