Question 1

Who is the manufacturer of ACP KINETIC TEST (ACID PHOSPHATASE TEST)?

Accepted Answer

Sclavo, Inc. filed the 510(k) submission for ACP KINETIC TEST (ACID PHOSPHATASE TEST) (K881204).

Question 2

What is the FDA product code for ACP KINETIC TEST (ACID PHOSPHATASE TEST)?

Accepted Answer

CKB. It is classified under 21 CFR 862.1020 as a Class 2 device in the Clinical Chemistry panel.

Question 3

When was ACP KINETIC TEST (ACID PHOSPHATASE TEST) cleared by the FDA?

Accepted Answer

Apr 28, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for ACP KINETIC TEST (ACID PHOSPHATASE TEST)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ACP KINETIC TEST (ACID PHOSPHATASE TEST)?

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	K881204
Device Name	ACP KINETIC TEST (ACID PHOSPHATASE TEST)
Applicant	Sclavo, Inc.
Product Code	CKB · Clinical Chemistry
Decision Date	Apr 28, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1020
Device Class	Class 2

ACP KINETIC TEST (ACID PHOSPHATASE TEST)

Device Facts

Regulatory Classification

Identification

Special Controls