Cleared Traditional

BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC. (K802451) - FDA 510(k) Clearance

Class I Chemistry device.

K802451 · Syn-Kit, Inc. · Chemistry device
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Jan 1981
Decision
93d
Days
Class 1
Risk

K802451 is an FDA 510(k) clearance for the BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC.. Classified as Nephelometric Method, Lipoproteins (product code JHQ), Class I - General Controls.

Submitted by Syn-Kit, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K802451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1980
Decision Date January 09, 1981
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHQ Nephelometric Method, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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.