Cleared Traditional

K780652 - HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (FDA 510(k) Clearance)

Class I Hematology device.

K780652 · The London Co. · Hematology device
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Jul 1978
Decision
101d
Days
Class 1
Risk

K780652 is an FDA 510(k) clearance for the HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2. Classified as Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide (product code JKS), Class I - General Controls.

Submitted by The London Co. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.3220 - the FDA hematology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K780652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1978
Decision Date July 27, 1978
Days to Decision 101 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 113d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3220
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.