Who is the manufacturer of HELENA FACTOR II DEFICIENT SUB. PLASMA?

Helena Laboratories filed the 510(k) submission for HELENA FACTOR II DEFICIENT SUB. PLASMA (K792336).

What is the FDA product code for HELENA FACTOR II DEFICIENT SUB. PLASMA?

GGP. It is classified under 21 CFR 864.7290 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for HELENA FACTOR II DEFICIENT SUB. PLASMA?

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

Who can help prepare an FDA 510(k) submission like HELENA FACTOR II DEFICIENT SUB. PLASMA?

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.

HELENA FACTOR II DEFICIENT SUB. PLASMA

K792336 · Helena Laboratories · GGP · Dec 27, 1979 · Hematology

Device Facts

Record ID	K792336
Device Name	HELENA FACTOR II DEFICIENT SUB. PLASMA
Applicant	Helena Laboratories
Product Code	GGP · Hematology
Decision Date	Dec 27, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
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...

HELENA FACTOR II DEFICIENT SUB. PLASMA

Device Facts

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

HELENA FACTOR II DEFICIENT SUB. PLASMA

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!