510(k) K893975
- Device
- Double Antibody Glucagon
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- 510(k) number
- K893975
- Product code
- JME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-31
- Date received
- 1989-06-02
- Regulation
- 862.1335
- Classification name
- Radioimmunoassay, Glucagon
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH ASARCH
- Address
- 5700 W. 96th St. Los Angeles CA US 90045 90045
FDA Registration Numbers#
- 8010132
- 3009335633
- 3008198807
- 1222302
- 2032839
- 3003356736
Source Documents#
510(k) summary PDF not indicated by FDA