Question 1

Who is the manufacturer of RIA SYS. FOR HUMAN GROWTH HORMONE?

Accepted Answer

Calbiochem-Behring Corp. filed the 510(k) submission for RIA SYS. FOR HUMAN GROWTH HORMONE (K780347).

Question 2

What is the FDA product code for RIA SYS. FOR HUMAN GROWTH HORMONE?

Accepted Answer

CFL. It is classified under 21 CFR 862.1370 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was RIA SYS. FOR HUMAN GROWTH HORMONE cleared by the FDA?

Accepted Answer

Apr 12, 1978 (decision: SESE).

Question 4

What is the regulatory pathway for RIA SYS. FOR HUMAN GROWTH HORMONE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like RIA SYS. FOR HUMAN GROWTH HORMONE?

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	K780347
Device Name	RIA SYS. FOR HUMAN GROWTH HORMONE
Applicant	Calbiochem-Behring Corp.
Product Code	CFL · Clinical Chemistry
Decision Date	Apr 12, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1370
Device Class	Class 1

RIA SYS. FOR HUMAN GROWTH HORMONE

Device Facts

Regulatory Classification

Identification