Question 1

Who is the manufacturer of ROCHE REAGENT FOR APOLIPOPROTEIN B?

Accepted Answer

Roche Diagnostic Systems, Inc. filed the 510(k) submission for ROCHE REAGENT FOR APOLIPOPROTEIN B (K910552).

Question 2

What is the FDA product code for ROCHE REAGENT FOR APOLIPOPROTEIN B?

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 ROCHE REAGENT FOR APOLIPOPROTEIN B cleared by the FDA?

Accepted Answer

May 7, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for ROCHE REAGENT FOR APOLIPOPROTEIN B?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ROCHE REAGENT FOR APOLIPOPROTEIN B?

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	K910552
Device Name	ROCHE REAGENT FOR APOLIPOPROTEIN B
Applicant	Roche Diagnostic Systems, Inc.
Product Code	MSJ · Clinical Chemistry
Decision Date	May 7, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1475
Device Class	Class 1

ROCHE REAGENT FOR APOLIPOPROTEIN B

Device Facts

Regulatory Classification

Identification