510(k) K955881
- Device
- Retinol Binding Rid Kit
- Applicant
- THE BINDING SITE, LTD.
- 510(k) number
- K955881
- Product code
- CZS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-22
- Date received
- 1995-12-28
- Regulation
- 866.5765
- Classification name
- Retinol-Binding Protein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY H GELLER
- Address
- East Tower, Suite 600 2425 W. Olympic Blvd. Santa Monica CA US 90404 90404
FDA Registration Numbers#
- 3013059683
- 3003423869
- 3002800697
- 3009189893
- 9610806
- 2032900
- 9610099
- 3017379203
- 3005452690
- 2245285
- 3003741796
- 3014325803
Source Documents#
510(k) summary PDF not indicated by FDA