Question 1

Who is the manufacturer of ENZYMATIC TRIGLYCERIDE?

Accepted Answer

Harleco filed the 510(k) submission for ENZYMATIC TRIGLYCERIDE (K760029).

Question 2

What is the FDA product code for ENZYMATIC TRIGLYCERIDE?

Accepted Answer

CDT. It is classified under 21 CFR 862.1705 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was ENZYMATIC TRIGLYCERIDE cleared by the FDA?

Accepted Answer

Sep 15, 1976 (decision: SESE).

Question 4

What is the regulatory pathway for ENZYMATIC TRIGLYCERIDE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ENZYMATIC TRIGLYCERIDE?

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	K760029
Device Name	ENZYMATIC TRIGLYCERIDE
Applicant	Harleco
Product Code	CDT · Clinical Chemistry
Decision Date	Sep 15, 1976
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1705
Device Class	Class 1

ENZYMATIC TRIGLYCERIDE

Device Facts

Regulatory Classification

Identification