Cleared Traditional

PLATELET AGGREGATION REAGENTS

K922800 · Chrono-Log Corp. · Hematology
Aug 1992
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K922800 is an FDA 510(k) clearance for the PLATELET AGGREGATION REAGENTS, a Reagent, Platelet Aggregation (Class II — Special Controls, product code GHR), submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on August 26, 1992, 77 days after receiving the submission on June 10, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K922800 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 1992
Decision Date August 26, 1992
Days to Decision 77 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GHR — Reagent, Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700

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