510(k) K853261
- Device
- Laser Rbp Laser(retinol Binding Protein Reagents)
- Applicant
- BEHRING DIAGNOSTICS, INC.
- 510(k) number
- K853261
- Product code
- CZS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-22
- Date received
- 1985-08-02
- Regulation
- 866.5765
- Classification name
- Retinol-Binding Protein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN E HUGHES
- Address
- 10933 No Torrey Pines Rd. La Jolla CA US 92037 92037
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