Who is the manufacturer of ABNORMAL REFERENCE PLASMA-VIII?

Medical Diagnostic Technologies, Inc. filed the 510(k) submission for ABNORMAL REFERENCE PLASMA-VIII (K895503).

What is the FDA product code for ABNORMAL REFERENCE PLASMA-VIII?

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

What is the regulatory pathway for ABNORMAL REFERENCE PLASMA-VIII?

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

Who can help prepare an FDA 510(k) submission like ABNORMAL REFERENCE PLASMA-VIII?

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.

ABNORMAL REFERENCE PLASMA-VIII

K895503 · Medical Diagnostic Technologies, Inc. · GJT · Oct 6, 1989 · Hematology

Device Facts

Record ID	K895503
Device Name	ABNORMAL REFERENCE PLASMA-VIII
Applicant	Medical Diagnostic Technologies, Inc.
Product Code	GJT · Hematology
Decision Date	Oct 6, 1989
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...

ABNORMAL REFERENCE PLASMA-VIII

Device Facts

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

ABNORMAL REFERENCE PLASMA-VIII

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!