Cleared Traditional

ADP REAGENT, MODIFIED

K952252 · Helena Laboratories · Hematology
Sep 1995
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K952252 is an FDA 510(k) clearance for the ADP REAGENT, MODIFIED, a Reagent, Platelet Aggregation (Class II — Special Controls, product code GHR), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on September 8, 1995, 116 days after receiving the submission on May 15, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K952252 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1995
Decision Date September 08, 1995
Days to Decision 116 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GHR — Reagent, Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700

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