Centocor Aggrestat, Collagen Reagent, Control Reagent

FDA 510(k) K954997 · Centocor, Inc.

Substantially Equivalent

510(k) numberK954997

Submission

Device name
Centocor Aggrestat, Collagen Reagent, Control Reagent
Applicant
Centocor, Inc.
Malvern, PA, US
Received
November 1, 1995
Decision date
January 24, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOZ – System, Automated Platelet Aggregation
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5700
Specialty
Hematology

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Questions and answers

When was Centocor Aggrestat, Collagen Reagent, Control Reagent cleared by the FDA?

Centocor Aggrestat, Collagen Reagent, Control Reagent (K954997) received a 510(k) decision of Substantially Equivalent on January 24, 1996, 84 days after the submission was received.

What is the product code of K954997?

The FDA product code is JOZ – System, Automated Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.