Cleared Traditional

K840210 - REPTILASE-R HA35

K840210 is an FDA 510(k) clearance for REPTILASE-R HA35, manufactured by Wellcome Diagnostics. The device is a Class 2 Hematology device with product code JCO cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K840210 · Wellcome Diagnostics · Hematology device
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Apr 1984
Decision
95d
Days
Class 2
Risk

K840210 is an FDA 510(k) clearance for the REPTILASE-R HA35. Classified as Bothrops Atrox Reagent (product code JCO), Class II - Special Controls.

Submitted by Wellcome Diagnostics (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8100 - 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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FDA 510(k) Submission Details - K840210

510(k) Number K840210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date April 23, 1984
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCO Device Classification - Class 2, Special Controls

Product Code JCO Bothrops Atrox Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8100
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.