Cleared Traditional

SERIES 810 PLATELET ANALYZER

K803128 · J.T. Baker Chemical Co. · Hematology
Apr 1981
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K803128 is an FDA 510(k) clearance for the SERIES 810 PLATELET ANALYZER, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by J.T. Baker Chemical Co. (Walker, US). The FDA issued a Cleared decision on April 3, 1981, 112 days after receiving the submission on December 12, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K803128 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1980
Decision Date April 03, 1981
Days to Decision 112 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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