Cleared Traditional

CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592

K962426 · Chrono-Log Corp. · Hematology
Oct 1996
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K962426 is an FDA 510(k) clearance for the CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on October 22, 1996, 120 days after receiving the submission on June 24, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K962426 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1996
Decision Date October 22, 1996
Days to Decision 120 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOZ — System, Automated Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700

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