Question 1

Who is the manufacturer of APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN?

Accepted Answer

Photec Diagnostics, Inc. filed the 510(k) submission for APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN (K853174).

Question 2

What is the FDA product code for APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN?

Accepted Answer

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

Question 3

When was APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN cleared by the FDA?

Accepted Answer

Aug 22, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN?

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	K853174
Device Name	APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN
Applicant	Photec Diagnostics, Inc.
Product Code	MSJ · Clinical Chemistry
Decision Date	Aug 22, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1475
Device Class	Class 1

APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN

Device Facts

Regulatory Classification

Identification