Question 1

Who is the manufacturer of EMIT CLINICAL PROCESSOR-CP 5000?

Accepted Answer

Syva Co. filed the 510(k) submission for EMIT CLINICAL PROCESSOR-CP 5000 (K792129).

Question 2

What is the FDA product code for EMIT CLINICAL PROCESSOR-CP 5000?

Accepted Answer

JQP. It is classified under 21 CFR 862.2100 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was EMIT CLINICAL PROCESSOR-CP 5000 cleared by the FDA?

Accepted Answer

Nov 13, 1979 (decision: SESE).

Question 4

What is the regulatory pathway for EMIT CLINICAL PROCESSOR-CP 5000?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like EMIT CLINICAL PROCESSOR-CP 5000?

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	K792129
Device Name	EMIT CLINICAL PROCESSOR-CP 5000
Applicant	Syva Co.
Product Code	JQP · Clinical Chemistry
Decision Date	Nov 13, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2100
Device Class	Class 1

EMIT CLINICAL PROCESSOR-CP 5000

Device Facts

Regulatory Classification

Identification