Question 1

Who is the manufacturer of IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM?

Accepted Answer

Dynatech Laboratories, Inc. filed the 510(k) submission for IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (K894645).

Question 2

What is the FDA product code for IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM?

Accepted Answer

JTC. It is classified under 21 CFR 866.2500 as a Class 1 device in the Microbiology panel.

Question 3

When was IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM cleared by the FDA?

Accepted Answer

Oct 17, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM?

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	K894645
Device Name	IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
Applicant	Dynatech Laboratories, Inc.
Product Code	JTC · Microbiology
Decision Date	Oct 17, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.2500
Device Class	Class 1

IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM

Device Facts

Regulatory Classification

Identification