Question 1

Who is the manufacturer of A FLUOROMETER?

Accepted Answer

American Diagnostic Corp. filed the 510(k) submission for A FLUOROMETER (K813540).

Question 2

What is the FDA product code for A FLUOROMETER?

Accepted Answer

KHO. It is classified under 21 CFR 862.2560 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was A FLUOROMETER cleared by the FDA?

Accepted Answer

Dec 31, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for A FLUOROMETER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like A FLUOROMETER?

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	K813540
Device Name	A FLUOROMETER
Applicant	American Diagnostic Corp.
Product Code	KHO · Clinical Chemistry
Decision Date	Dec 31, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2560
Device Class	Class 1

A FLUOROMETER

Device Facts

Regulatory Classification

Identification