Cleared Traditional

ADP REAGENT

K910800 · Helena Laboratories · Hematology
May 1991
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K910800 is an FDA 510(k) clearance for the ADP REAGENT, a Reagent, Platelet Aggregation (Class II — Special Controls, product code GHR), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on May 20, 1991, 84 days after receiving the submission on February 25, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K910800 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1991
Decision Date May 20, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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

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