Cleared Traditional

K893894 - CHARISE CHARLES REAGENT BLOOD STRIPS

K893894 is an FDA 510(k) clearance for CHARISE CHARLES REAGENT BLOOD STRIPS, manufactured by Lee Import Domestic Consulting. The device is a Class 2 Hematology device with product code JIO cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K893894 · Lee Import Domestic Consulting · Hematology device
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Jul 1989
Decision
58d
Days
Class 2
Risk

K893894 is an FDA 510(k) clearance for the CHARISE CHARLES REAGENT BLOOD STRIPS. Classified as Blood, Occult, Colorimetric, In Urine (product code JIO), Class II - Special Controls.

Submitted by Lee Import Domestic Consulting (Orlando, US). The FDA issued a Cleared decision on July 27, 1989 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - 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 Lee Import Domestic Consulting devices

FDA 510(k) Submission Details - K893894

510(k) Number K893894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1989
Decision Date July 27, 1989
Days to Decision 58 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 113d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIO Device Classification - Class 2, Special Controls

Product Code JIO Blood, Occult, Colorimetric, In Urine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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.