Arterial Micro Collection Kit

FDA 510(k) K833312 · Current Technologies, Inc.

Substantially Equivalent

510(k) numberK833312

Submission

Device name
Arterial Micro Collection Kit
Applicant
Current Technologies, Inc.
Mchenry, IL, US
Received
September 22, 1983
Decision date
December 8, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1675
Specialty
Clinical Chemistry

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K251812Steripath® Flow™ Blood Collection SystemJKA · Traditional Magnolia Medical Technologies09/25/2025SE
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More from Sol-Millennium Medical, Inc.

510(k)DeviceDecision
K810816Prefilled Arterial Blood Sampling SyringJKA · Traditional 04/07/1981SE
K802185Arterial Blood Sampling KitFMP · Traditional 10/10/1980SE

Questions and answers

When was Arterial Micro Collection Kit cleared by the FDA?

Arterial Micro Collection Kit (K833312) received a 510(k) decision of Substantially Equivalent on December 8, 1983, 77 days after the submission was received.

What is the product code of K833312?

The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.