Question 1

Who is the manufacturer of MULTI ANALYTE MIXTURE, CALIBRATORS?

Accepted Answer

Phoenix Diagnostics, Inc. filed the 510(k) submission for MULTI ANALYTE MIXTURE, CALIBRATORS (K902675).

Question 2

What is the FDA product code for MULTI ANALYTE MIXTURE, CALIBRATORS?

Accepted Answer

JIX. It is classified under 21 CFR 862.1150 as a Class 2 device in the Clinical Chemistry panel.

Question 3

When was MULTI ANALYTE MIXTURE, CALIBRATORS cleared by the FDA?

Accepted Answer

Jul 31, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for MULTI ANALYTE MIXTURE, CALIBRATORS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MULTI ANALYTE MIXTURE, CALIBRATORS?

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	K902675
Device Name	MULTI ANALYTE MIXTURE, CALIBRATORS
Applicant	Phoenix Diagnostics, Inc.
Product Code	JIX · Clinical Chemistry
Decision Date	Jul 31, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1150
Device Class	Class 2

MULTI ANALYTE MIXTURE, CALIBRATORS

Device Facts

Regulatory Classification

Identification

Special Controls