Cleared Traditional

HEMOCUE PHOTOMETER TECHNICAL MANUAL (K832020) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832020 · Aktiebolaget Leo Diagnostics · Hematology device
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Oct 1983
Decision
135d
Days
Class 2
Risk

K832020 is an FDA 510(k) clearance for the HEMOCUE PHOTOMETER TECHNICAL MANUAL. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Aktiebolaget Leo Diagnostics (Walker, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - 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.

View all Aktiebolaget Leo Diagnostics devices

Submission Details

510(k) Number K832020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1983
Decision Date October 28, 1983
Days to Decision 135 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 113d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKR System, Hemoglobin, Automated

All 38
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IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995