Cleared Special

K062430 - HEMOSIL PROTEIN C

K062430 is an FDA 510(k) clearance for HEMOSIL PROTEIN C, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GGP cleared through the Special 510(k) pathway after a 11-day FDA review.

K062430 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
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Sep 2006
Decision
11d
Days
Class 2
Risk

K062430 is an FDA 510(k) clearance for the HEMOSIL PROTEIN C. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 1, 2006 after a review of 11 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K062430

510(k) Number K062430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2006
Decision Date September 01, 2006
Days to Decision 11 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 113d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

GGP Device Classification - Class 2, Special Controls

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 151
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