Cleared Traditional

K780455 - QUANTITATIVE DETERMINATION OF PORPHYRINS

K780455 is an FDA 510(k) clearance for QUANTITATIVE DETERMINATION OF PORPHYRINS, manufactured by Whale Scientific, Inc.. The device is a Class 1 Chemistry device with product code JKJ cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K780455 · Whale Scientific, Inc. · Chemistry device
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Jul 1978
Decision
129d
Days
Class 1
Risk

K780455 is an FDA 510(k) clearance for the QUANTITATIVE DETERMINATION OF PORPHYRINS. Classified as Fluorometric Measurement, Porphyrins (product code JKJ), Class I - General Controls.

Submitted by Whale Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1595 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Whale Scientific, Inc. devices

FDA 510(k) Submission Details - K780455

510(k) Number K780455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1978
Decision Date July 27, 1978
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 88d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

JKJ Device Classification - Class 1, General Controls

Product Code JKJ Fluorometric Measurement, Porphyrins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1595
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.