Cleared Traditional

K864701 - VWF IMMUNOBLOT

K864701 is the FDA 510(k) clearance for VWF IMMUNOBLOT by Ramco Laboratories, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K864701 · Ramco Laboratories, Inc. · Hematology device
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Mar 1987
Decision
118d
Days
Class 2
Risk

K864701 is an FDA 510(k) clearance for the VWF IMMUNOBLOT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Ramco Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on March 30, 1987 after a review of 118 days - within the typical 510(k) review window.

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: 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 Ramco Laboratories, Inc. devices

Submission Details

510(k) Number K864701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date March 30, 1987
Days to Decision 118 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 113d · This submission: 118d
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
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K864701.
ASSERACHROM PROTEIN S TEST KIT
K872479 · American Bioproducts Co. · Aug 1987
STACHROM PROTEIN C TEST KIT
K871039 · American Bioproducts Co. · May 1987
PROTEIN S CONTROL PLASMA
K870917 · American Bioproducts Co. · Apr 1987
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)
K870353 · American Dade · Feb 1987
IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)
K870354 · American Dade · Feb 1987
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
K864480 · Instrumentation Laboratory CO · Jan 1987