Retinol Binding Protein RBP Rid Kit

FDA 510(k) K973189 · The Binding Site, Ltd.

Substantially Equivalent

510(k) numberK973189

Submission

Device name
Retinol Binding Protein RBP Rid Kit
Applicant
The Binding Site, Ltd.
Santa Monica, CA, US
Received
August 25, 1997
Decision date
September 29, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CZS – Retinol-Binding Protein, Antigen, Antiserum, Control
Device class
Class I (low risk)
Regulation
21 CFR 866.5765
Specialty
Immunology

Other 510(k)s with product code CZS

510(k)DeviceApplicantDecision
K955881Retinol Binding Rid KitCZS · Traditional The Binding Site, Ltd.03/22/1996SE
K853261Laser RBP Laser(Retinol Binding Protein Reagents)CZS · Traditional Behring Diagnostics, Inc.08/22/1985SE

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Questions and answers

When was Retinol Binding Protein RBP Rid Kit cleared by the FDA?

Retinol Binding Protein RBP Rid Kit (K973189) received a 510(k) decision of Substantially Equivalent on September 29, 1997, 35 days after the submission was received.

What is the product code of K973189?

The FDA product code is CZS – Retinol-Binding Protein, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5765.