Who is the manufacturer of FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2?

More Diagnostics filed the 510(k) submission for FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 (K932657).

What is the FDA product code for FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2?

DAP. It is classified under 21 CFR 864.7320 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2?

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

Who can help prepare an FDA 510(k) submission like FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2?

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.

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2

K932657 · More Diagnostics · DAP · Nov 2, 1993 · Hematology

Device Facts

Record ID	K932657
Device Name	FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2
Applicant	More Diagnostics
Product Code	DAP · Hematology
Decision Date	Nov 2, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7320
Device Class	Class 2

Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2

Device Facts

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2

Device Facts

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!