Cleared Traditional

COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (K833708) - FDA 510(k) Clearance

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

K833708 · Worthington Diagnostic Systems · Hematology device
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Jan 1984
Decision
76d
Days
Class 2
Risk

K833708 is an FDA 510(k) clearance for the COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE. Classified as Red-cell Count By Photometry (product code LKZ), Class II - Special Controls.

Submitted by Worthington Diagnostic Systems (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7100 - 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: 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 Worthington Diagnostic Systems devices

Submission Details

510(k) Number K833708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1983
Decision Date January 04, 1984
Days to Decision 76 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 113d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKZ Red-cell Count By Photometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7100
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.