Question 1

Who is the manufacturer of RAICHEM HDL-CHOLESTEROL REAGENT?

Accepted Answer

Reagents Applications, Inc. filed the 510(k) submission for RAICHEM HDL-CHOLESTEROL REAGENT (K830207).

Question 2

What is the FDA product code for RAICHEM HDL-CHOLESTEROL REAGENT?

Accepted Answer

LBR. It is classified under 21 CFR 862.1475 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was RAICHEM HDL-CHOLESTEROL REAGENT cleared by the FDA?

Accepted Answer

Mar 21, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for RAICHEM HDL-CHOLESTEROL REAGENT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like RAICHEM HDL-CHOLESTEROL REAGENT?

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	K830207
Device Name	RAICHEM HDL-CHOLESTEROL REAGENT
Applicant	Reagents Applications, Inc.
Product Code	LBR · Clinical Chemistry
Decision Date	Mar 21, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1475
Device Class	Class 1

RAICHEM HDL-CHOLESTEROL REAGENT

Device Facts

Regulatory Classification

Identification