Question 1

Who is the manufacturer of ALT S.C.E. (GPT)?

Accepted Answer

J. D. Assoc. filed the 510(k) submission for ALT S.C.E. (GPT) (K863053).

Question 2

What is the FDA product code for ALT S.C.E. (GPT)?

Accepted Answer

CKA. It is classified under 21 CFR 862.1030 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was ALT S.C.E. (GPT) cleared by the FDA?

Accepted Answer

Dec 10, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for ALT S.C.E. (GPT)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ALT S.C.E. (GPT)?

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	K863053
Device Name	ALT S.C.E. (GPT)
Applicant	J. D. Assoc.
Product Code	CKA · Clinical Chemistry
Decision Date	Dec 10, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1030
Device Class	Class 1

ALT S.C.E. (GPT)

Device Facts

Regulatory Classification

Identification