Cleared Traditional

K841708 - MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII

K841708 is the FDA 510(k) clearance for MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII by Meloy Laboratories, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K841708 · Meloy Laboratories, Inc. · Hematology device
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Jul 1984
Decision
87d
Days
Class 2
Risk

K841708 is an FDA 510(k) clearance for the MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Meloy Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on July 19, 1984 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Meloy Laboratories, Inc. devices

Submission Details

510(k) Number K841708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date July 19, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 113d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
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