Cleared Traditional

DIGICLOT 2-#820

K812121 · Volu Sol Medical Industries · Hematology
Nov 1981
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K812121 is an FDA 510(k) clearance for the DIGICLOT 2-#820, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981, 112 days after receiving the submission on July 27, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K812121 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1981
Decision Date November 16, 1981
Days to Decision 112 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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