Cleared Traditional

RNA MEDICAL HEMAT CONTROL

K955630 · Bionostics, Inc. · Hematology
Mar 1996
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K955630 is an FDA 510(k) clearance for the RNA MEDICAL HEMAT CONTROL, a Electrolyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJR), submitted by Bionostics, Inc. (Acton, US). The FDA issued a Cleared decision on March 1, 1996, 81 days after receiving the submission on December 11, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K955630 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1995
Decision Date March 01, 1996
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JJR — Electrolyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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