Question 1

Who is the manufacturer of AIA-PACK FT3 ASSAY?

Accepted Answer

Tosoh Medics, Inc. filed the 510(k) submission for AIA-PACK FT3 ASSAY (K963687).

Question 2

What is the FDA product code for AIA-PACK FT3 ASSAY?

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 AIA-PACK FT3 ASSAY cleared by the FDA?

Accepted Answer

Nov 8, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for AIA-PACK FT3 ASSAY?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like AIA-PACK FT3 ASSAY?

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	K963687
Device Name	AIA-PACK FT3 ASSAY
Applicant	Tosoh Medics, Inc.
Product Code	CDP · Clinical Chemistry
Decision Date	Nov 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1710
Device Class	Class 2

AIA-PACK FT3 ASSAY

Device Facts

Regulatory Classification

Identification