Question 1

Who is the manufacturer of PHENYLALANINE UV KINETIC TEST KIT?

Accepted Answer

Biochemicals, Inc. filed the 510(k) submission for PHENYLALANINE UV KINETIC TEST KIT (K813171).

Question 2

What is the FDA product code for PHENYLALANINE UV KINETIC TEST KIT?

Accepted Answer

JNB. It is classified under 21 CFR 862.1555 as a Class 2 device in the Clinical Chemistry panel.

Question 3

When was PHENYLALANINE UV KINETIC TEST KIT cleared by the FDA?

Accepted Answer

Dec 3, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for PHENYLALANINE UV KINETIC TEST KIT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PHENYLALANINE UV KINETIC TEST KIT?

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	K813171
Device Name	PHENYLALANINE UV KINETIC TEST KIT
Applicant	Biochemicals, Inc.
Product Code	JNB · Clinical Chemistry
Decision Date	Dec 3, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1555
Device Class	Class 2

PHENYLALANINE UV KINETIC TEST KIT

Device Facts

Regulatory Classification

Identification