Cleared Traditional

O.O2 M CALCIUM CHLORIDE SOLUTION

K870688 · U. S. Diagnostics, Inc. · Hematology
Mar 1987
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K870688 is an FDA 510(k) clearance for the O.O2 M CALCIUM CHLORIDE SOLUTION, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on March 31, 1987, 40 days after receiving the submission on February 19, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K870688 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1987
Decision Date March 31, 1987
Days to Decision 40 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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