Question 1

Who is the manufacturer of MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER?

Accepted Answer

Nova Biomedical Corp. filed the 510(k) submission for MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER (K002613).

Question 2

What is the FDA product code for MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER?

Accepted Answer

CHL. It is classified under 21 CFR 862.1120 as a Class 2 device in the Clinical Chemistry panel.

Question 3

When was MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER cleared by the FDA?

Accepted Answer

Oct 19, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER?

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	K002613
Device Name	MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
Applicant	Nova Biomedical Corp.
Product Code	CHL · Clinical Chemistry
Decision Date	Oct 19, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1120
Device Class	Class 2

MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER

Device Facts

Regulatory Classification

Identification