Cleared Traditional

EPINEPHRINE REAGENT, CAT. NO. 5367

K910680 · Helena Laboratories · Hematology
May 1991
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K910680 is an FDA 510(k) clearance for the EPINEPHRINE REAGENT, CAT. NO. 5367, 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, 94 days after receiving the submission on February 15, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K910680 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1991
Decision Date May 20, 1991
Days to Decision 94 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

Similar Devices — GHR Reagent, Platelet Aggregation

All 10
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
K061991 · Helena Laboratories · Feb 2007
ADP REAGENT, MODIFIED
K952252 · Helena Laboratories · Sep 1995
PLATELET AGGREGATION REAGENTS
K922800 · Chrono-Log Corp. · Aug 1992
COLLAGEN REAGENT CAT. NO. 5368
K910706 · Helena Laboratories · May 1991
ADP REAGENT
K910800 · Helena Laboratories · May 1991
PLATELET AGGREGATION REAGENTS
K910286 · Medical Diagnostic Technologies, Inc. · Mar 1991