Question 1

Who is the manufacturer of MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY?

Accepted Answer

Ciba Corning Diagnostics Corp. filed the 510(k) submission for MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY (K884769).

Question 2

What is the FDA product code for MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY?

Accepted Answer

CEM. It is classified under 21 CFR 862.1600 as a Class 2 device in the Clinical Chemistry panel.

Question 3

When was MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY cleared by the FDA?

Accepted Answer

Jan 17, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY?

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	K884769
Device Name	MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
Applicant	Ciba Corning Diagnostics Corp.
Product Code	CEM · Clinical Chemistry
Decision Date	Jan 17, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1600
Device Class	Class 2

MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY

Device Facts

Regulatory Classification

Identification