Reaads Protein S Antigen Test Kit

FDA 510(k) K972482 · Reaads Medical Products, Inc.

Substantially Equivalent

510(k) numberK972482

Submission

Device name
Reaads Protein S Antigen Test Kit
Applicant
Reaads Medical Products, Inc.
Westminster, CO, US
Received
July 2, 1997
Decision date
August 13, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GGP – Test, Qualitative And Quantitative Factor Deficiency
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7290
Specialty
Hematology

Other 510(k)s with product code GGP

510(k)DeviceApplicantDecision
K251440CRYOcheck Chromogenic Factor VIIIGGP · Traditional Precision Biologic, Inc.08/25/2025SE
K230852HemosIL Chromogenic Factor IXGGP · Traditional Instrumentation Laboratory Company12/13/2023SE
K220728vWF AgGGP · Traditional Siemens Healthcare Diagnostics Products GmbH06/02/2023SE
K214002CRYOcheck Chromogenic Factor IXGGP · Traditional Precision Biologic, Inc.12/23/2022SE
K223402HemosIL von Willebrand Factor AntigenGGP · Special Instrumentation Laboratory CO12/09/2022SE
K200033HemosIL von Willebrand Factor AntigenGGP · Special Instrumentation Laboratory CO08/19/2020SE
K193204Cryocheck Chromogenic Factor VIIIGGP · Traditional Precision Biologic07/17/2020SE
K183440CRYOcheck FVIII Inhibitor KitGGP · Traditional Precision Biologic, Inc.03/12/2019SE
K181525INNOVANCE Free PS AgGGP · Traditional Siemens Healthcare Diagnostics Products GmbH09/07/2018SE
K133005Hemosil Von Willebrand Activity AssayGGP · Special Instrumentation Laboratory CO03/13/2014SE

More from Instrumentation Laboratory CO

510(k)DeviceDecision
K972342Reaads Protein C Antigen Test KitGGP · Traditional 10/06/1997SE
K972005Reaads Von Willebrand Factor Antigen Test KitGGP · Traditional 08/13/1997SE
K952287Reaads Anti-Phosphatidylserine Quantitative Test KitMID · Traditional 12/18/1995SE

Questions and answers

When was Reaads Protein S Antigen Test Kit cleared by the FDA?

Reaads Protein S Antigen Test Kit (K972482) received a 510(k) decision of Substantially Equivalent on August 13, 1997, 42 days after the submission was received.

What is the product code of K972482?

The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.