Cleared Traditional

ARTAP ARTERIAL BLOOD SAMPLING DEVICE

K843360 · Analytical Products, Inc. · Hematology

Oct 1984

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K843360 is an FDA 510(k) clearance for the ARTAP ARTERIAL BLOOD SAMPLING DEVICE, a Arterial Blood Sampling Kit (Class I — General Controls, product code CBT), submitted by Analytical Products, Inc. (Belmont, US). The FDA issued a Cleared decision on October 31, 1984, 64 days after receiving the submission on August 28, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 868.1100.

Submission Details

510(k) Number	K843360 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 1984
Decision Date	October 31, 1984
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—

Device Classification

Product Code	CBT — Arterial Blood Sampling Kit
Device Class	Class I — General Controls
CFR Regulation	21 CFR 868.1100
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.