Question 1

Who is the manufacturer of BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119?

Accepted Answer

Biocheck, Inc. filed the 510(k) submission for BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 (K003851).

Question 2

What is the FDA product code for BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119?

Accepted Answer

DCK. It is classified under 21 CFR 866.5270 as a Class 2 device in the Immunology panel.

Question 3

When was BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 cleared by the FDA?

Accepted Answer

Jul 20, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119?

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	K003851
Device Name	BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
Applicant	Biocheck, Inc.
Product Code	DCK · Immunology
Decision Date	Jul 20, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5270
Device Class	Class 2

BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119

Device Facts

Regulatory Classification

Identification