Cleared Traditional

PIASTRINIT

K863114 · J. D. Assoc. · Hematology
Nov 1986
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K863114 is an FDA 510(k) clearance for the PIASTRINIT, a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on November 6, 1986, 85 days after receiving the submission on August 13, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number K863114 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1986
Decision Date November 06, 1986
Days to Decision 85 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGK — Products, Red-cell Lysing Products
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8540

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