Question 1

Who is the manufacturer of CODE-A-WELL  350 MICROTITRATION STRIPS?

Accepted Answer

Plastic Injectors, Inc. filed the 510(k) submission for CODE-A-WELL  350 MICROTITRATION STRIPS (K842848).

Question 2

What is the FDA product code for CODE-A-WELL  350 MICROTITRATION STRIPS?

Accepted Answer

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

Question 3

When was CODE-A-WELL  350 MICROTITRATION STRIPS cleared by the FDA?

Accepted Answer

Sep 7, 1984 (decision: SESE).

Question 4

What is the regulatory pathway for CODE-A-WELL  350 MICROTITRATION STRIPS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CODE-A-WELL  350 MICROTITRATION STRIPS?

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	K842848
Device Name	CODE-A-WELL 350 MICROTITRATION STRIPS
Applicant	Plastic Injectors, Inc.
Product Code	JTC · Microbiology
Decision Date	Sep 7, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.2500
Device Class	Class 1

CODE-A-WELL 350 MICROTITRATION STRIPS

Device Facts

Regulatory Classification

Identification