Question 1

Who is the manufacturer of AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA?

Accepted Answer

Amersham Corp. filed the 510(k) submission for AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA (K860252).

Question 2

What is the FDA product code for AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA?

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 AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA cleared by the FDA?

Accepted Answer

Feb 11, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA?

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	K860252
Device Name	AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA
Applicant	Amersham Corp.
Product Code	CDP · Clinical Chemistry
Decision Date	Feb 11, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1710
Device Class	Class 2

AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA

Device Facts

Regulatory Classification

Identification