Cleared Traditional

I-STAT SYSTEM

K992571 · I-Stat Corp. · Hematology
Feb 2000
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K992571 is an FDA 510(k) clearance for the I-STAT SYSTEM, a Activated Whole Blood Clotting Time (Class II — Special Controls, product code JBP), submitted by I-Stat Corp. (East Windsor, US). The FDA issued a Cleared decision on February 10, 2000, 192 days after receiving the submission on August 2, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7140.

Submission Details

510(k) Number K992571 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1999
Decision Date February 10, 2000
Days to Decision 192 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JBP — Activated Whole Blood Clotting Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7140

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