Who is the manufacturer of STA-LIATEST FREE PROTEIN S TEST KIT?

Diagnostica Stago, Inc. filed the 510(k) submission for STA-LIATEST FREE PROTEIN S TEST KIT (K010963).

What is the FDA product code for STA-LIATEST FREE PROTEIN S TEST KIT?

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

What is the regulatory pathway for STA-LIATEST FREE PROTEIN S TEST KIT?

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

Who can help prepare an FDA 510(k) submission like STA-LIATEST FREE PROTEIN S TEST KIT?

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.

STA-LIATEST FREE PROTEIN S TEST KIT

K010963 · Diagnostica Stago, Inc. · GGP · Jun 6, 2001 · Hematology

Device Facts

Record ID	K010963
Device Name	STA-LIATEST FREE PROTEIN S TEST KIT
Applicant	Diagnostica Stago, Inc.
Product Code	GGP · Hematology
Decision Date	Jun 6, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

Sort by

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...

STA-LIATEST FREE PROTEIN S TEST KIT

Device Facts

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

STA-LIATEST FREE PROTEIN S TEST KIT

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!