Question 1

Who is the manufacturer of CORNING'S MAGIC T3(125I) RADIOIMMUNO-?

Accepted Answer

Corning Medical & Scientific filed the 510(k) submission for CORNING'S MAGIC T3(125I) RADIOIMMUNO- (K832353).

Question 2

What is the FDA product code for CORNING'S MAGIC T3(125I) RADIOIMMUNO-?

Accepted Answer

CDP. It is classified under 21 CFR 862.1710 as a Class 2 device in the Clinical Chemistry panel.

Question 3

When was CORNING'S MAGIC T3(125I) RADIOIMMUNO- cleared by the FDA?

Accepted Answer

Aug 31, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for CORNING'S MAGIC T3(125I) RADIOIMMUNO-?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CORNING'S MAGIC T3(125I) RADIOIMMUNO-?

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	K832353
Device Name	CORNING'S MAGIC T3(125I) RADIOIMMUNO-
Applicant	Corning Medical & Scientific
Product Code	CDP · Clinical Chemistry
Decision Date	Aug 31, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1710
Device Class	Class 2

CORNING'S MAGIC T3(125I) RADIOIMMUNO-

Device Facts

Regulatory Classification

Identification