Aptt-Es Reagent

FDA 510(k) K934351 · Medical Diagnostic Technologies, Inc.

Substantially Equivalent

510(k) numberK934351

Submission

Device name
Aptt-Es Reagent
Applicant
Medical Diagnostic Technologies, Inc.
Ventura, CA, US
Received
September 7, 1993
Decision date
December 6, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GFO – Activated Partial Thromboplastin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7925
Specialty
Hematology

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Questions and answers

When was Aptt-Es Reagent cleared by the FDA?

Aptt-Es Reagent (K934351) received a 510(k) decision of Substantially Equivalent on December 6, 1993, 90 days after the submission was received.

What is the product code of K934351?

The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.