Question 1

Who is the manufacturer of GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*?

Accepted Answer

Harleco filed the 510(k) submission for GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* (K772033).

Question 2

What is the FDA product code for GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*?

Accepted Answer

JMK. It is classified under 21 CFR 862.1380 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* cleared by the FDA?

Accepted Answer

Nov 17, 1977 (decision: SESE).

Question 4

What is the regulatory pathway for GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*?

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	K772033
Device Name	GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
Applicant	Harleco
Product Code	JMK · Clinical Chemistry
Decision Date	Nov 17, 1977
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1380
Device Class	Class 1

GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*

Device Facts

Regulatory Classification

Identification