Reaads Anti-Phosphatidylserine Quantitative Test Kit

FDA 510(k) K952287 · Reaads Medical Products, Inc.

Substantially Equivalent

510(k) numberK952287

Submission

Device name
Reaads Anti-Phosphatidylserine Quantitative Test Kit
Applicant
Reaads Medical Products, Inc.
Westminister, CO, US
Received
May 16, 1995
Decision date
December 18, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MID – System, Test, Anticardiolipin Immunological
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Specialty
Immunology

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Questions and answers

When was Reaads Anti-Phosphatidylserine Quantitative Test Kit cleared by the FDA?

Reaads Anti-Phosphatidylserine Quantitative Test Kit (K952287) received a 510(k) decision of Substantially Equivalent on December 18, 1995, 216 days after the submission was received.

What is the product code of K952287?

The FDA product code is MID – System, Test, Anticardiolipin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5660.