Question 1

Who is the manufacturer of PIPETTE 12 CHANNEL?

Accepted Answer

Organon Teknika Corp. filed the 510(k) submission for PIPETTE 12 CHANNEL (K831644).

Question 2

What is the FDA product code for PIPETTE 12 CHANNEL?

Accepted Answer

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

Question 3

When was PIPETTE 12 CHANNEL cleared by the FDA?

Accepted Answer

Aug 1, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for PIPETTE 12 CHANNEL?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PIPETTE 12 CHANNEL?

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	K831644
Device Name	PIPETTE 12 CHANNEL
Applicant	Organon Teknika Corp.
Product Code	JTC · Microbiology
Decision Date	Aug 1, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.2500
Device Class	Class 1

PIPETTE 12 CHANNEL

Device Facts

Regulatory Classification

Identification