Question 1

Who is the manufacturer of AUTOMATED BLOOD CELL SEPARATOR?

Accepted Answer

Cryosan, Inc. filed the 510(k) submission for AUTOMATED BLOOD CELL SEPARATOR (K830831).

Question 2

What is the FDA product code for AUTOMATED BLOOD CELL SEPARATOR?

Accepted Answer

LKN. as a Class U device in the HE panel.

Question 3

When was AUTOMATED BLOOD CELL SEPARATOR cleared by the FDA?

Accepted Answer

Jun 16, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for AUTOMATED BLOOD CELL SEPARATOR?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like AUTOMATED BLOOD CELL SEPARATOR?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K830831
Device Name	AUTOMATED BLOOD CELL SEPARATOR
Applicant	Cryosan, Inc.
Product Code	LKN · HE
Decision Date	Jun 16, 1983
Decision	SESE
Submission Type	Traditional
Device Class	Class U

AUTOMATED BLOOD CELL SEPARATOR

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