Cleared Traditional

K102164 - HEMOSIL PROTEIN S ACTIVITY ASSAY (FDA 510(k) Clearance)

K102164 · Instrumentation Laboratory CO · Hematology device
Mar 2011
Decision
227d
Days
Class 2
Risk

K102164 is an FDA 510(k) clearance for the HEMOSIL PROTEIN S ACTIVITY ASSAY. This device is classified as a Test, Qualitative And Quantitative Factor Deficiency (Class II - Special Controls, product code GGP).

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on March 17, 2011, 227 days after receiving the submission on August 2, 2010.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K102164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date March 17, 2011
Days to Decision 227 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

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