Cleared Traditional

CALCIUM CHLORIDE

K853246 · Bio/Data Corp. · Hematology
Aug 1985
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K853246 is an FDA 510(k) clearance for the CALCIUM CHLORIDE, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on August 13, 1985, 12 days after receiving the submission on August 1, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K853246 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1985
Decision Date August 13, 1985
Days to Decision 12 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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