Cleared Traditional

SPECTROLYSE HEPARIN (ANTI-IIA)

K972209 · Medical Diagnostic Technologies, Inc. · Hematology
Aug 1997
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K972209 is an FDA 510(k) clearance for the SPECTROLYSE HEPARIN (ANTI-IIA), a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on August 12, 1997, 62 days after receiving the submission on June 11, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K972209 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 1997
Decision Date August 12, 1997
Days to Decision 62 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code KFF — Assay, Heparin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7525

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