Question 1

Who is the manufacturer of MULTICHEM ENZYMATIC CHOLESTEROL SYS?

Accepted Answer

Simmler, Inc. filed the 510(k) submission for MULTICHEM ENZYMATIC CHOLESTEROL SYS (K831700).

Question 2

What is the FDA product code for MULTICHEM ENZYMATIC CHOLESTEROL SYS?

Accepted Answer

CHH. It is classified under 21 CFR 862.1175 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was MULTICHEM ENZYMATIC CHOLESTEROL SYS cleared by the FDA?

Accepted Answer

Jul 19, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for MULTICHEM ENZYMATIC CHOLESTEROL SYS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MULTICHEM ENZYMATIC CHOLESTEROL SYS?

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	K831700
Device Name	MULTICHEM ENZYMATIC CHOLESTEROL SYS
Applicant	Simmler, Inc.
Product Code	CHH · Clinical Chemistry
Decision Date	Jul 19, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1175
Device Class	Class 1

MULTICHEM ENZYMATIC CHOLESTEROL SYS

Device Facts

Regulatory Classification

Identification